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*UPGRADE IN PROGRESS* -- CareerCircle is upgrading its capabilities and as a result the system may be temporarily unavailable as we bring new capabilities and infrastructure online to better serve our members.&nbsp; If you receive an error during this timeframe please bear with us as we're working to improve our system and you may need to retry that operation at a later time.&nbsp; &nbsp;

Job Description The Quality Control Senior Specialist plays a critical role in ensuring the quality of our products by managing laboratory data and overseeing the review of microbiological, chemical, and analytical data. This role requires close collaboration with various teams including Production, Quality Assurance, Validation and Facilities, as well as external resources, when necessary, to support manufacturing processes. Responsibilities of the Quality Control Senior Specialist include leading routine testing of products, driving continuous process improvements, troubleshooting issues, and providing support for investigational testing. Additionally, the role entails writing Standard Operating Procedures (SOPs) to maintain consistent and high-quality laboratory practices. Responsibilities <ul><li>Reviews and authorizes microbiological testing data</li><li>Reviews and authorizes environmental monitoring data to include active air and surface sampling and water sampling</li><li>Performs Critical Site Review (CSR) for production processes</li><li>Evaluates data, conducts trouble shooting, process improvements, report writing, involvement in interdepartmental committees and projects</li><li>Initiate and lead Change Requests utilizing IPI</li><li>Participate in Quality Risk Assessments</li><li> Authors standard operating procedures (SOPs) </li><li>Collaborate with internal customers and vendors to identify, evaluate and implement new analytical technologies that expand site capabilities</li><li>Apply project management concepts and techniques as they relate to analytical testing, regulatory requirements for assay development/validation, project timelines and budgeting</li><li>Build knowledge of the company, processes, and internal/external customers</li><li>Build and maintain strong relationships with site leadership, stakeholders, and customers</li><li>Build relationships to work in a highly functioning diverse team environment</li><li>Applies team effectiveness skills, listening and integrating diverse perspectives from across the work group; contributes and adds value to the achievement of team goals</li><li>Understand and apply cGMP/GLP, Compendial, and other applicable regulatory requirements toward analytical testing</li><li>Capability to function effectively within an automated/electronic laboratory environment</li></ul>This position is based on-site with a schedule of Mon-Fri, 8am-5pm with occasional weekend work. Education Minimum Requirement and Experience: <ul><li>Bachelor's degree of science (BS) in science, Engineering, or related areas of study with five (5) years' work experience in a pharmaceutical, manufacturing, laboratory, or related environment. OR</li><li>Master's degree of science (MS) in science, Engineering, or related areas of study with three (3) years' work experience in a pharmaceutical, manufacturing, laboratory, or related environment.</li></ul> Required Experience and Skills: <ul><li>Fully trained in GMP data review/authorization. </li><li>Experience and working knowledge of IPI Change Request system and process.</li><li> Strong verbal and written communication skills. </li><li>Supports site, divisional and Quality initiatives.</li><li>Reviews and approves SOPs for Quality and supporting departments.</li><li>Experience with SAP and LIMS.</li><li>BCG Production Medical Clearance</li></ul> Preferred Experience and Skills: <ul><li>Experience with eLogs and Trackwise</li><li>Ability to gown aseptically</li><li> Experience with aseptic processing operations such as cell culture, filling, and lyophilization </li></ul>NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 05/26/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/26/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R296839

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Senior Specialist, Quality Control

Job Description Position Description: Associate Specialist - Operations Support The Enabling Facilities (EF) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual to work in a fast-paced job that provides a high degree of technical and project management responsibility. The Associate Specialist -Operations Support position will report to the Associate Director, Engineering and will be a member of the EF Team at the Rahway NJ facility. This position will be a member of the Prep Lab team which is responsible for interfacing with scientists who are manufacturing drug substance to enable early clinical studies, scaling up new chemistries, and exploring new technologies. Primary Responsibilities of the Associate Specialist - Operations Support include the following: The Operations Support role involves working directly with the Prep Lab lead supporting scientific teams who are preparing for manufacturing drug substance to supply material for both development work and clinical studies in our kg scale (Prep Lab) and pilot scale facilities. This work involves collaborating with teams to understand their raw material needs, sourcing and ordering those raw materials, and ensuring that the materials arrive on site in time. The Associate Specialist will also work with Procurement, when necessary, on special requests and to leverage their contacts and expertise. In addition, the Associate Specialist will be responsible for ensuring that the material ordered is compliant with various site requirements (e.g., environment and safety) and other regulations as needed, and that the entire team is kept abreast of the status of the raw materials within the material ordering process. In addition to sourcing and ordering raw materials for the Prep Lab and pilot scale facilities, the Associate Specialist will order supplies, as needed, for other members of the scientific staff in the department. This often involves networking with suppliers and collaborating across the network. Other responsibilities include submitting paperwork to the site logistics group to enable scientists to ship samples both domestically and internationally in support of various research programs. The Associate Specialist will also be expected to lead process improvement initiatives (such as a project to collate raw material sourcing data into a searchable database) to enhance the efficiency and effectiveness of the overall sourcing process. Additional Responsibilities: The Associate Specialist may also work with the Prep Lab staff to ensure that the facility runs smoothly. A specific area of focus will be the PAT (Process Analytical Technology) equipment that scientists use to implement analytical methods that can interface directly with the process stream to monitor and control the process. As time permits, the Associate Specialist will be responsible for supporting the existing PAT equipment (FBRM, React IR, EasySampler, pH meter, RX10, Raman) and looking for opportunities to use additional equipment. Position Qualifications: Education Minimum Requirement: <ul><li>Bachelor's degree in Chemical Engineering, Chemistry, Biology, Pharmaceutical Sciences or related scientific or technical field (with expected completion no later than December 2024).</li></ul> Required Experience and Skills: <ul><li>Effective interpersonal and communication skills, both verbal and written.</li><li>Excellent organizational skills</li><li>Proficiency with MS Office products</li><li>Desire and willingness to learn, contribute and lead.</li><li>Track-record of independent problem-solving.</li><li>Demonstrated ability to prioritize tasks and manage multiple responsibilities.</li></ul>Preferred Experience and Skills:<ul><li>Strong abilities in stakeholder management and building cross-functional networks.</li><li>Experience in collaborating with vendors or other external partners.</li><li>Experience with small molecule drug substance raw materials sourcing and/or ordering.</li><li>Excellent ability to effectively communicate with different professional levels and external stakeholders.</li><li>Ability to work effectively across boundaries and build strong collaborative relationships with other groups.</li><li>Automation or programming experience</li><li>Analytical chemistry or Process Analytical Technology experience</li></ul> NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. #EligibleforERP Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $68,400.00 - $107,700.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 05/30/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/30/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R296206

Associate Specialist - Operations Support

Job Description Device Development Principal Scientist - Device Development Lead (Director Equivalent) Our company's Device Development (DD) Team designs, develops, and commercializes novel biologic/drug/vaccine - device enabled combination products to achieve safe and effective delivery to their intended site of action. The DD Team manages the development of the device constituent of our company's pipeline of combination products across a variety of therapy areas and routes of administration including inhalation, implantation, and injection. Job description This position will be responsible for applying their knowledge of product and process development in the (bio)pharmaceutical and/or medical device industries to set tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes. This position interacts extensively with subject-matter experts on the DD team and members of internal cross-functional product development teams from concept through product launch. Additionally, the position will ensure products and processes are developed in accordance with applicable regulatory, quality, company, and customer requirements. This position will lead cross-functional development teams within and external to Device Development. The incumbent must be able to work well with all levels of employees and be able to effectively coordinate the execution of device development strategies. This individual will be expected to apply his/her knowledge of product design and development; manufacturing process development, qualification, and validation; and, design control and risk management techniques to positively support and influence clinical and commercial combination product development and launches. Principal Responsibilities<ul><li>Lead and set direction for the device development strategy for multiple vaccine development programs ranging from concept generation/selection through commercialization and launch readiness:<ul><li>Lead the Device Development Engineering Core teams focused on development of design requirements for the combination product and engineering execution against the established requirements.</li><li>Lead the cross-functional Device Working Groups to ensure full integration of the device development activities with the clinical, regulatory, formulation, commercial and other key company functions.</li><li>Represent Device Development and the project-specific Device Working Groups on cross-functional teams, including the Development and Commercialization Team (DCT). Additionally, maintain engagement with Early Development Teams (EDT) and Product Development Teams (PDT)</li><li>Serve as key point-of-contact with potential external device designers, developers, and suppliers for select device technology platforms.</li><li>Maintain a high level of engagement in all device development activities (e.g. engineering design, engineering analysis and testing, medical device design controls, risk management, test method/fixture development, design verification and validation, injection molding, automated assembly, and human factors analysis)</li><li>Maintain a high level of engagement in the program-specific design controls process and design history file development.</li><li>Author and review relevant portions of the regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs under your leadership.</li><li>Remain current in relevant worldwide regulatory guidance and standards.</li><li>Lead/support/oversee clinical supplies production with respect to device component manufacture and final assembly of biologic/drug product with device constituent part.</li><li>Lead/support the development, implementation and continuous improvement of Device Development and Device Project Leader processes, procedures, and tools.</li><li>Proactively resolve project obstacles and challenges and communicate device development strategy, design controls and risk management approaches within Device Development and with external suppliers</li><li>Enhance our Company's professional image and competitive advantage through publications, presentations, patents, and professional activities</li><li>Stay current with relevant regulations, technologies, standards, and effectively share this knowledge with others</li></ul></li></ul>Qualifications REQUIREMENTS:<ul><li>B.A./B.S in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering, or other types of engineering plus a minimum of 10 years of combined experience in medical device and combination product development.</li><li>5+ years of leadership experience with deep working knowledge of device, biologic/drug product, and process development including regulatory submission and approval processes. Including development drug-device combination product or a medical device component of a combination product.</li><li>Has broad knowledge of medical device development, design controls and risk management, alongside deep knowledge in device design, requirement management, FMEA, design verification, design validation, statistical sampling, and control strategy.</li><li>Knowledge of U.S. and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human Factors guidance, ISO 14971, 11608 and 11040, EN 62366, Council Directive 93/42/EEC, etc.</li><li>Proven track record of applying analytical skills in product design, development, and validation</li><li>Self-motivated with ability to work independently</li><li>Proven ability to lead team members of diverse skill sets and backgrounds</li><li>Strong interpersonal skills and a strategic thinker; able to influence without formal authority; ability to influence and present ideas to senior leadership</li><li>Excellent communication, presentation, negotiation, project management, and organizational skills</li><li>Experience with leading development projects at an enterprise level</li><li>Willing to travel</li><li>Able to multi-task continuously</li></ul> #EligibleforERP NOTICEFORINTERNALAPPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $149,400.00 - $235,100.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: Hazardous Material(s): Job Posting End Date: 06/6/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:06/06/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R296151

Principal Scientist - Device Project Lead

Job Description West Point Technical Operations is seeking highly motivated individuals to provide engineering technical support for a vaccine packaging facility. The focus areas of the role include (1) planning and execution of packaging projects via Change Control processes and (2) packaging Artwork workflow execution and coordination. Additional areas of responsibility include Deviation Management, protocol development and execution, shop floor support of technical issues and management of the update of Packaging Master Batch Records. Limited additional shift or weekend coverage may be required based on specific assignments. The individual in this position will be responsible for the following: <ul><li>Authoring and approving Change Control documentation for process, equipment, serialization and product launch projects. Managing on-time implementation and close-out to meet project, production and supply timelines. </li><li>Coordination and execution of Packaging Artwork workflow processes and projects in support of new and revised artwork.</li><li> Performing deviation investigations aimed to prevent deviation recurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting product impact assessment. Where applicable, complete investigational test protocols to determine root cause, product impact, event scope, etc. </li><li>Collaboration across IPT functional areas to drive robust processing and continuous improvement. Continuous improvement may include proactive process improvements, investigation Corrective/Preventative Actions (CAPAs), or value capture projects that seek to improve yield, reduce cost, or lower cycle times.</li><li>Providing on-the-floor support of operational and technical issues; providing immediate responses on the shop floor to deviations and potential deviations.</li><li>Supporting team and IPT safety, environmental, and compliance objectives.</li><li>Managing investigation, change request and project timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans when possible.</li><li> Conducts and designs experimental protocols </li><li>Actively using and championing the use of our Company's production system tools, both in problem solving and day-to-day operational activities.</li><li>Authoring and updating technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation</li><li>Authoring notifications to applicable Health Authorities, in response to deviations or complaints, as required.</li><li>Supports and/or executes continuous improvement projects that increase compliance, simplify/ standardize and/or gain efficiencies.</li><li>Provides technical support to manufacturing for complex problems and issues including process/equipment.</li><li>Collaborates effectively with the area Operators/Mechanics, support groups, Quality, and Planning.</li></ul> Required Education / Experience: <ul><li>Bachelor's degree in chemical engineering, mechanical engineering, biological sciences, packaging, or related discipline, or equivalent work experience.</li><li>Minimum 1-year experience in pharmaceutical research, manufacturing, or packaging</li></ul> Strongly Preferred Experience and Skills: <ul><li>Packaging or vaccine/pharmaceutical manufacturing experience (Operations, Technology, or Quality)</li><li>Change Control Projects</li><li>Deviation management</li><li>IPI, MEDS, SAP</li><li>Technical writing (e.g. investigations, technical protocols/reports)</li><li>Investigative tools (e.g. 5-whys, fishbone).</li><li>Experience in applying our Company's production system tools and mindset, both in problem solving and day-to-day operational activities</li></ul>NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. VETJOBS Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: Yes Hazardous Material(s): N/A Job Posting End Date: 05/26/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/26/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R296154

Packaging Technical Operations, Specialist, Engineering

Job Description Job Description: The West Point PV (Polysaccharide Vaccine) organization is seeking a highly motivated Specialist within the PV E2E Tech Ops Projects team. The successful candidate will have the opportunity to contribute to the performance and results of the manufacturing area by providing engineering/technical guidance and support for process, equipment, facility and analytical projects of varying complexity and size. The Specialist: <ul><li>Supports, executes, and/or leads process, equipment, and facility projects for the PV E2E.</li><li>Supports, executes, and/or leads continuous improvement projects that increase compliance, reduce cost, and/or simplify/standardize the process. </li><li>Examines complex issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) to best understand and resolve the root cause.</li><li>Authors, updates, and/or reviews and approves engineering, technical, and manufacturing documents (change control, validation documents, commissioning documents, etc.) necessary for engineering studies and project execution in a Good Manufacturing Practice environment.</li><li>Provides on-the-floor support for project implementation and studies, as required.</li><li>Leads or participates in Quality Risk Assessments.</li><li>Supports team safety, environmental, and compliance objectives.</li><li>Manages project timelines to ensure key compliance and customer due dates are met; escalates any potential delays and develop remediation plans when possible.</li><li>Collaborates effectively with Operations, Quality, Planning, project teams, and external vendors.</li></ul> Education Minimum Requirement: <ul><li>B.S. or B.A. in Engineering, Sciences, or related discipline</li></ul> Required Experience and Skills: <ul><li>Minimum two (2) years post-bachelor's degree experience in a regulated environment.</li><li>Experience in project support and/or change control and/or bio-pharm equipment and/or equipment/process validation.</li><li>Highly developed communication, leadership, and teamwork skills.</li><li>Ability to manage projects/work to schedule/deadlines.</li></ul> Preferred Experience and Skills: <ul><li>Experience in biologics, vaccine, or bulk sterile manufacturing facilities and equipment. </li><li>Change Control author.</li><li>Project Management</li><li>Six Sigma training</li></ul>NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. VETJOBS Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 05/25/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/25/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R296180

Specialist, Engineering

Job Description Our Company's Oncology organization is dedicated to delivering breakthrough innovations that extend and improve the lives of cancer patients worldwide. Our team of dauntless, forward-thinking individuals achieves this through an unwavering dedication to supporting accessibility to medicine, providing new therapeutic procedures, and collaborating with governments and payers to ensure that people who need medicines have access to them. At our Company, our focus is on innovation and launch execution excellence; we translate breakthrough science into innovative medicines that help people with cancer across the globe. Working with the Asset Development Team (ADT's), early- & late-stage clinical development teams, the Biomarker (BMx) leads will develop asset-specific clinical biomarker strategy by incorporating critical insight from discovery biology, clinical development, diagnostics, bioinformatics, molecular assay experts, Quantitative Pharmacology Pharmacometrics (QP2) and Biostatistics and Research Decision Sciences (BARDS). Location: this role can be based in Rahway, NJ, Upper Gwynedd, PA, Boston, MA, or S. San Francisco, CA. This position does not offer remote work arrangement and requires daily in-office presence. KEY RESPONSIBILITIES:<ul><li>Identify asset-specific translational deliverables & gaps. Building testable hypothesis & forming BMx strategy: collaborate across different LFs, to formulate testable clinical and translational hypotheses; and develop clinical biomarker and translational research strategy to test the hypothesis. </li><li>Alignment, risk mitigation & strategy implementation: align with asset development team strategy. Build critical scientific insight to identify gaps and risks, pro-actively develop mitigation plans. Work with matrixed stakeholders to ensure implementation. </li><li>Collaborate with Asset Development Teams, Early Development Teams; Product Development Teams, Clinical Trial Teams, Discovery, Informatics; Diagnostics, quantitative modeling team; Biostats, Molecular Assay teams, and other key LFs to author protocol-specific biomarker plans and ensure their efficient implementation. </li><li>Incorporate cutting edge scientific and technical advances to support clinical developments. Proactively identify and engage external KOL's on specific hypothesis-driven collaborations to complement internal effort. Drive the publication of biomarker and translational research for respective studies.</li><li>Analysis, interpretation & impact: collaborate with forementioned line functions to build formal analysis plans, participate in data analysis and interpretation. Effectively communicate the study plan, update and output across different function areas to for optimal impact on projects. </li><li>Contribute to Health Authority engagements; Registrational Effort and Post Marketing Commitments.</li><li>The individual is in translational research and biomarker development for our Company's Oncology programs. Working with early- and/or late-stage clinical development teams, he/she will have the opportunity to drive translational research and clinical biomarker development for critical oncology clinical programs. The individual will assume a role in a dynamic, cross-functional environment as a key member in early- and/or late-stage development teams and work closely with multiple functional line functions in various scientific and operational aspects of translational research and biomarker development. </li></ul>Key responsibilities include, but are not limited to the following:<ul><li>Hypothesis-building & strategy forming: collaborate with stakeholders in clinical development team(s), to formulate testable clinical hypothesis and develop clinical biomarker and translational research strategy to test the hypothesis. </li><li>Alignment, risk mitigation & strategy implementation: align the development team strategy with broader portfolio strategy. Build critical scientific insight to identify gaps and risks, pro-actively develop mitigation plans. Work with matrixed stakeholders to ensure implementation. </li><li>Analysis, interpretation & impact: collaborate with line function experts to build formal analysis plans, participate in data analysis and interpretation. Effectively communicate the study plan, update and output across different function areas to for optimal impact on projects. </li></ul>Specific responsibilities include, but are not limited to the following:<ul><li>Work closely with Product Development Team and/or Early Development Team stakeholders. Set protocol-level, hypothesis-driven translational science and biomarker strategy. </li><li>Collaborate with clinical and companion diagnostic leads, author protocol-specific biomarker plans and ensure their efficient implementation. Co-lead a regularly scheduled biomarker meeting for the development team (s).</li><li>Collaborate with experimental experts, bio-informatics experts, statisticians and clinical stakeholders to build formal statistical analysis plans, analysis reports and data communication plans. Participate in data analysis and interpretation. </li><li>Interface with translational and discovery laboratories to drive implementation of preclinical/translational projects based on emerging clinical/translational datasets.</li><li>Incorporate cutting edge scientific and technical advances to support clinical developments. Proactively identify and engage external KOL's on specific hypothesis-driven collaborations to complement internal effort.</li><li>Drive the publication of biomarker and translational research for respective studies.</li></ul>Qualifications:<ul><li>PH.D. M.D or M.D./Ph.D. with a minimum of 8 years' experience in oncology biomarker studies and translational clinical research, or comparable experience.</li><li>Minimum of 2 years experience in pharma or similar industry setting.</li></ul>Required:<ul><li>Must have experience in clinical trial development and execution; clear strategic view on the Translational needs in clinical studies; Experience & familiarity with experimental and bioinformatic aspects of translational research and biomarker development. </li><li>Strong interpersonal skills, as well as the ability to function in a team environment are essential</li><li>A proven track record in biomedical research is essential;</li><li>Demonstrated record of scientific scholarship and achievement;</li><li>Ability to demonstrate a broad understanding of the end-to-end drug and diagnostic development process, and specific expertise in oncology, preferably immuno-oncology</li><li>Possess communication and analytical skills to regularly interface with a wide variety of stakeholders within the organization, as well as with external clinicians and scientists</li><li>Proven track record in cross-functional, highly matrixed collaborative groups on drug discovery and/or clinical development.</li></ul>Preferred:<ul><li>Prior experience in drug discovery in oncology</li><li>Prior experience in communication with health authorities</li><li>Specific expertise in immunology and/or immuno-oncology</li><li>Experience in companion diagnostics development</li><li>Project experience in biomarker discovery, biomarker and diagnostic development, and early or late drug development is desired. </li></ul> NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $181,600.00 - $285,800.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 06/8/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:06/08/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R295662

Principal Scientist (Director), Oncology Translational Science & Clinical Biomarkers

Job Description Position Description: Senior Specialist, Engineering This position resides within the Site Services Organization and is responsible for providing leadership and direction for the Integrated Facility Management (IFM) program in the Southeastern Pennsylvania region. This role involves collaborating with external partners and cross-functional teams to operate and maintain buildings and building systems to support our Research & Development Division and corporate functions effectively and safely. Primary Activities<ul><li>Responsible for overseeing day-to-day tactical operations and strategic planning for one or more of the following sites: West Point, Upper Gwynedd, North Wales (NW), Spring House (SH) and WeWork Philly</li><li>Oversees and manages quality compliance for IFM and GxP activities performed by IFM partners, including management of change and investigations.</li><li>Coordinates facility related activities for GWES Facility Operations in the SE PA Region.</li><li>Ensure IFM partners meet all contractual obligations including all Service Level Agreements (SLA's) and Key Performance Indicators (KPI's).</li><li>Identifies, enables, and takes calculated risks to challenge norms and execute opportunities that will drive efficiencies and create value.</li><li>Works collaboratively across the organization, building bridges across teams, functions, divisions, geographies, external stakeholders, and customers to support the best outcome for the company.</li><li>Defines and executes consistent processes to improve value, ensure continued delivery of products and services, and sustain long-term growth.</li><li>Applies knowledge of quality, regulatory, environmental, health, and safety requirements and effectively partners with experts to ensure a safe and compliant environment.</li><li>Assesses the degree of change required, manages, and minimizes associated risks, and brings stakeholders and team members through phases of commitment to drive successful execution and implementation of the change.</li><li>Develops site-based facility strategies for business continuity, building operation, and asset life cycle management to improve current service and uptime while generating new service offerings that create value for our company.</li><li>Understands workplace strategy and research and analytic methodologies, works across the organization, and implements workplace strategies to advance organizational objectives.</li><li>Works with cross-functional teams to deliver efficient and productive services effectively and safely at a competitive cost. </li><li>Provides direction and leadership for regional IFM initiative implementation and sustainability of processes.</li></ul> Position Qualifications : Education Minimum Requirement: <ul><li>Required - BA/BS degree with 3 years in engineering, science, facilities management, quality management and/or business. </li></ul>Required Experience and Skills: <ul><li>Must demonstrate an excellent understanding of quality, compliance and change control as it relates to facility operations.</li><li>Understanding of finance and cash flow with respect to corporate purchasing.</li><li>Knowledge and experience in project and facilities management.</li><li>Demonstrated communication, leadership, teamwork, and customer service skills.</li><li>Demonstrated technical and problem-solving abilities.</li><li>Demonstrated computer skills using MS Office Suite (Outlook, Word, Excel, PowerPoint, etc.)</li></ul>Preferred Experience and Skills:<ul><li>Lean, Six Sigma Yellow Belt certification or equal experience in application.</li><li>Experience with external partner management and agencies.</li><li>Additional professional designations including Project Management, Change Management, etc.</li><li>Knowledge of office and/or lab-based site compliance.</li></ul>NOTICEFORINTERNALAPPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 25% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: Yes Hazardous Material(s): n/a Job Posting End Date: 06/1/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:06/01/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R294989

Senior Specialist, Engineering

Job Description We invite you to join our Team! Building 63A Syringe Filling Facility Project team is seeking a highly motivated individual to fill an open position to lead the start-up and tech transfer for a new vaccine formulation & filling facility at the West Point site. Facility start-up will include design, commissioning, equipment qualification and vaccine drug product process demonstration in support of facility licensure. The Senior Specialist, Technical Operations is responsible for providing technical assist for Commissioning & Qualification and automation recipe development while actively drafting change request, single use design, MES , and protocols for Tech transfer, Process Performance Qualifications. In this role, the Specialist will work as an individual contributor as well as a lead co-ordination for different workstreams within a cross-functional group that includes Global Engineering Services, Global Technical Operations, West Point Operations, Quality, Automation, and others. Additional responsibilities may include: <ul><li> Partner with cross functional team to develop process/procedures and complete successful qualification of equipment/processes. </li><li> Provide technical expertise for unit operation for design reviews, process hazard assessments, quality risk assessments, factory and site acceptance testing, qualification. </li><li> Assist successful demonstration of unit operations for the technology transfer of vaccine manufacturing process to the new manufacturing facility. </li><li> Assist single use workstream End to End activities. </li><li> Author and update technical and manufacturing documents necessary for process design/definition, engineering studies, process demonstrations, and validation. </li><li> Develop and execute change control inclusive of change definition, risk assessments, impact assessments, task execution, implementation, and support of associated regulatory filings. </li><li> Assist process improvement projects and complex manufacturing investigations during development, engineering and Process Performance Qualifications batches execution. </li><li> Examine issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause. </li><li> Assist regulatory submission preparation and inspections for the facility. </li><li> Lead the integrated Deviation Management team once that facility reaches operational state </li></ul> Minimum Requirements: <ul><li> Bachelor 's Degree in an Engineering or Science Related field. </li><li> Minimum five (5) years of experience in GMP manufacturing and/or technical support of GMP manufacturing operations; Minimum four (4) years with a Master 's Degree . </li><li>Proficiency in English, in oral and written</li><li> Demonstrated a strong performance record and have excellent project management skills. </li><li> Experience in biologics, vaccine or bulk sterile manufacturing facilities. </li><li> Highly developed communication and teamwork skills. </li><li> Be able to work independently and drive significant portions of the project. </li><li> Willing to travel up to 10% </li></ul> Preferred Experience and Skills: <ul><li> Experience working with vaccines manufacturing process. </li><li> Experience with a Deviation Management program (Root Cause Analysis , Corrective/Preventative Actions, Human Performance, among others). </li><li> Skills with Digital and Data Visualization tools. </li></ul>Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 06/7/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:06/07/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R293405

Senior Specialist, Technical Operations

Job Description This role is positioned within the Veeva Vault Quality Platform Team, responsible for contributing to the technical solution design, implementation and continuous improvement of the Veeva Quality Suite. We collaborate internationally to deliver the services and solutions that help everyone to be more productive and enable innovation. Key Responsibilities : <ul><li>Technical Oversight of Company's Veeva Vault Quality</li><li>Provide Product expertise in Veeva Quality suite as a certified Vault platform administrator.</li><li>Support new business process implementations and configuration changes for Vault Quality.</li><li>Participate in impact assessment activities, reviewing proposed changes and ensuring impact understood across QMS and QualityDocs.</li><li> Coach and provide subject matter expertise to fellow team members. </li><li>Deliver product enhancements through agreed backlog process to ensure Veeva Vault Quality evolves to meet business needs</li><li>Ensure Quality Vault remains compliant as a Validated Solution through verification testing, documentation, and validation efforts</li><li>Collaborate across the Manufacturing IT & R&D IT Quality teams and work closely with Product Managers, Veeva Platform Lead, IT Architects, and Value/Product Line teams</li><li>Collaborate with Veeva Enterprise Managed Services on product features</li><li> Collaborate with Application Management Services team for end user support and system operations </li><li> Strong communication skills </li></ul> Knowledge/Education Required: <ul><li>Minimum Level of Education Required - Bachelor's Degree in Computer Science, Engineering, MIS, and Science OR in a related field. The job requires a solid academic background on how Information Technology supports the delivery of business objectives.</li><li>Preferred Level of Education - Veeva Certifications (Veeva Vault/Vault Quality Suite/ QMS). The role holder has completed the Certified Vault Training and is up to date.</li><li></li></ul>Required Experience and Skills :<ul><li>4+ year of Veeva Vault Quality experience .Veeva Quality Docs and QMS is a Validated SAAS application, and therefore documented certification and experience of working in a GxP environment is required.</li><li> Problem solving skills are required to solve business process issues identified in the backlog. </li><li> Additionally, the candidate may identify problems with the product and should be sufficiently skilled to confidently propose solutions to the Product Manager and if required work with the Vendor. </li><li> The candidate must not only understand the current configuration, but also look to best practices to best solve any new enhancements without impact on any other workflows that may share objects. </li><li> Written and verbal communication skills including the ability to communicate with both a business and a technical audience. </li><li> The ability to work independently and effectively as a team across global hubs, and maintain a highly collaborative, transparent effort. </li><li> Demonstrated ability to solve problems with a sense of ownership, enthusiasm, and innovation. </li><li> Ability to work in a global, multi-cultural, English-speaking environment </li></ul> Preferred Experience and Skills: <ul><li>Experience in IT Quality and relevant business areas</li><li>Understanding of Quality Management System Capabilities (Audit/Inspection , Change Control, Deviation/CAPA, Risk Management, Complaint Management & Supplier Quality Management)</li><li>Experience in solution delivery with GMP systems</li><li>Experience with architecture, integration, interfaces, portals, and/or analytics</li><li>Understanding of Systems Development Life Cycle (SDLC), and current Good Manufacturing Practice (cGMP) processes</li><li>Experience in an Agile environment</li></ul> What we need from you to be successful in this role: <ul><li>Problem solving skills are required to solve business process issues identified in the backlog.</li><li>Additionally, the candidate may identify problems with the product and should be sufficiently skilled to confidently propose solutions to the Product Manager and if required work with the Vendor.</li><li>The candidate must not only understand the current configuration, but also look to best practices to best solve any new enhancements without impact on any other workflows that may share objects.</li><li>Written and verbal communication skills including the ability to communicate with both a business and a technical audience.</li><li>The ability to work independently and effectively as a team across global hubs, and maintain a highly collaborative, transparent effort.</li><li>Demonstrated ability to solve problems with a sense of ownership, enthusiasm, and innovation</li><li>Ability to work in a global, multi-cultural, English-speaking environment</li></ul> NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Required Skills: Asset Management, Benefits Management, Management System Development, Product Management, Requirements Management, Stakeholder Relationship Management, Strategic Planning, System Designs Preferred Skills: Job Posting End Date: 06/5/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:06/05/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R293944

Veeva Vault Quality Solution Architect

Job Description This is Bio Manufacturing and Facilities Management position responsible for leading an established team of highly skilled Bio Process Engineers, Automation Engineers, A&E Design Professionals, Capital Construction Managers, Bio Manufacturing Process Maintenance, and Facilities Maintenance in a high-performance culture. The position will be Full-Time On-Site position at our company's Animal Health's 350-acre Bio Manufacturing and R&D facility located in De Soto Kansas - Kansas City Metro area. The selected candidate will be required to work occasional weekends and holidays based on the needs of the business. Warehouse and Packaging Manager serves on the site management team and supports the labeling packaging and distribution of animal vaccines. This position has a broad range of responsibilities with opportunities to grow and develop to higher levels of management within our company's Animal Health organization. Responsibilities: <ul><li>Manage day to day Bio Manufacturing and Facility support activities to ensure smooth and efficient production</li><li>Manage and motivate a team of warehouse and packaging employees. This would include coordination of additional labor, such as temporary employees or other departments</li><li>Administer all Human Resource (HR) programs, i.e. reviews, discipline, etc.</li><li>Oversee the training of job duties, safety procedures and maintain team morale</li><li>Implement and maintain procedures designed to control accurate physical inventories and the proper storage and handling of materials</li><li>Coordinate team efforts to label, pack, receive, store, and ship all materials using the SAP ATLAS operating system</li><li>Evaluate personnel and machinery requirements and make and/or implement recommendations for changes and improvements.</li><li>Monitor and enforce quality and productivity standards</li><li>Lead and institute data-based process improvements</li><li>Work closely with production, planning, purchasing and other facilities to assure an uninterrupted supply of materials required for production activities.</li><li>Manage the flow of materials, ensuring proper receipt, storage, disposition and documentation of these materials.</li><li>Manage the raw materials, labels, in-process materials, quarantine and finished goods in the warehouse cooler/freezer by interacting with production departments; managing the effectiveness of materials being stored and transferred in and out of the warehouse cooler.</li><li>Ensure the proper training of packaging and warehouse employees in the safe use of packaging and warehouse equipment</li><li>Oversee and perform the receiving, packaging, and warehousing functions. Ensure that all receiving functions comply with corporate requirements.</li><li>Ensure the safe and proper storage of all material.</li><li>Maintain updated and accurate information in SAP and other computerized systems by performing cycle count and other methods. Perform and provide oversight for the proper information entry into SAP for warehouse and production activities.</li></ul>The foregoing description is not intended and should not be construed to be an exhaustive list of all responsibilities, skills and efforts or work conditions associated with the job. It is intended to be an accurate reflection of the general nature and level of the job. Education<ul><li>High School diploma or equivalent</li></ul> Required Experience and Skills: <ul><li>3+ years of supervisory experience is required</li><li>Knowledge of packaging and warehousing and packaging and warehousing management systems is required</li><li>Excellent customer service focus and interpersonal skills is required</li><li>Ability to work with minimal supervision</li><li>Detail oriented, with an ability to manage multiple priorities</li><li>Must possess the ability to interface with and understand the production processes, timing and priorities for the area supported.</li><li>Must be flexible and able to manage multiple priorities.</li><li>Must be goal-oriented and able to manage risks.</li><li>Good verbal and written communication skills.</li></ul> Preferred Experience and Skills: <ul><li>Relevant work experience encompassing a working knowledge of USDA regulatory requirements</li><li>Knowledge and/or experience with formal problem-solving techniques as it relates to a hands-on approach to problem solving, such as root cause analysis and/or Lean tools</li><li>Working knowledge of GMPs and of regulatory requirements</li><li>Technical writing experience</li><li>E xperience with Packaging robots / automated packaging lines </li></ul>MSJR NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 06/5/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:06/05/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R295922

Packaging and Warehouse Manager

Job Description Responsibilities:<ul><li>Design, develop and maintain data pipelines to extract data from a variety of sources and populate data lake and data warehouse.</li><li>Work with data governance team and implement data quality checks and maintain data catalogs.</li><li>Use Orchestration, logging, and monitoring tools to build resilient pipelines.</li><li>Utilize test driven development methodology when building ELT/ETL pipelines.</li><li>Understand and apply concepts like data lake, data warehouse, lake-house, data mesh and data-fabric where relevant.</li><li>Develop data models for cloud data warehouses like Redshift and Snowflake.</li><li>Develop pipelines to ingest data into cloud data warehouses.</li><li>Analyze data using SQL and Collaborate with Data Analyst, Data scientists, Machine Learning Engineers to identify and transform data for ingestion, exploration, and modeling.</li><li>Use serverless AWS services like Glue, Lambda, StepFunctions.</li><li>Use Terraform Code to deploy on AWS.</li><li>Containerize Python code using Docker.</li><li>Use Git for version control and understand various branching strategies.</li><li>Build pipelines to work with large datasets using PySpark.</li><li>Develop proof of concepts using Jupyter Notebooks and create technical documentation as needed.</li></ul>Requirements:<ul><li>Bachelor's degree or equivalent in Mathematics, Computer Science, Engineering, Artificial Intelligence, or a related field and 5 years of experience in the position offered or related.</li><li>Must have 5 years of experience with all of the following: SQL and PySpark; Git, Docker, and Terraform; Agile Methodology; and experience with Jenkins pipelines.</li><li>Must have 1 year of experience with all of the following: feature engineering pipelines and re-useability in both training and inference stages; creating docker images for ML models and custom python scripts; operationalizing and governing machine learning models using AWS Sagemaker; designing, developing, and maintaining pipelines using Python and serverless AWS services; and AWS services like S3, ECS, Fargate, Glue, StepFunctions, CloudWatch, Lambda, and EMR.</li><li>10% domestic and international travel required by year.</li></ul>Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): No Job Posting End Date: 08/6/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:08/06/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R293352

Senior Specialist, Data Engineering (multiple openings)

Job Description Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products. We are seeking a Growth and Improvement minded Vaccine Manufacturing Manager that can help drive our Strategic Operating Priorities. <ul><li> Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs </li><li> Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business) </li><li> Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape </li><li> Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world </li><li> Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success - They are a Competitive Advantage for Us </li></ul> Key Responsibilities Employee Development & Leadership <ul><li> Work independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion </li></ul><ul><li> Models Company leadership principles and inclusive behaviors </li><li> Provides coaching and supports skills development and process capabilities within the IPT </li><li> Provides applicable feedback and coaching within the team during the Performance Management cycle and ensuring that Employee Development Plans (EDP's) are in place </li><li> Ensuring all operators receive appropriate training for all assigned tasks </li><li> Is accountable for the effective performance management of individuals in their teams </li></ul> Safety Compliance <ul><li> Demonstrates a strong compliance mind-set (EHS, Quality and Finance) and continuously sets a high standard for themselves and their Team | Ensure that all staff adhere to the Company Safety and Waste Management Policies </li><li> Ensures themselves and their team follow safe operating instructions for all tasks and equipment </li><li> Ensures that the right tools and equipment specified for the task are available and utilized </li><li> Ensures that the correct personal protective equipment required is available and utilized </li><li> Follow up any reported defects or workplace hazards immediately </li><li> Report all accidents, incidents and near misses within 24 hours and to participate in investigation and identification of effective corrective and preventative actions </li></ul> Quality Compliance <ul><li> Supports the on-time completion of Quality compliance tasks in relation to Deviation, CAPA and Change Control management </li><li> Supports all aspects of Quality Assurance including cGMP, RFT and good documentation practices and provides coaching to the rest of their team </li></ul> Productivity <ul><li> Manages the weekly and monthly schedule adherence of production activities within their department. </li><li> Contributes to creating a culture of continuous improvement and leads by example. </li><li> Sponsors effectives problem solving and ensures that resources are available. </li><li> Ensure visibility and communication of key productivity metrics with the teams. </li></ul> Financial <ul><li> Meeting agreed departmental budget for Spend, Transfers to Inventory (TTI), Discards and Headcount </li><li> Recognizes and investigates opportunities for financial savings </li></ul> Education <ul><li> High School Diploma/GED and five (5)+ years supervisory experience or military experience -OR- </li><li> B.S. within Science or Engineering with minimum of three (3)+ years manufacturing experience or military experience </li></ul> Required <ul><li> Three year's relevant work experience in GMP/USDA environment </li><li> Process knowledge of batching and filling equipment </li><li> Demonstrated written and verbal communications skills </li><li> Proficiency with automated systems </li><li> Experience training others and/or leading hands-on or instructor-led training </li><li> Problem solving skills </li><li> Experience with on-the-floor cGMP manufacturing and familiarity with regulatory requirements </li><li> Demonstrated ability to work both independently and as a part of a team </li></ul>MSJR NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 06/5/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:06/05/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R295413

Manager, Batching and Filling

Job Description<ul><li>Provide engineering and testing support for all current and future mobile infrastructure solutions.</li><li>Develop mobility strategic vision for the organization, through research and evaluation of new technologies.</li><li>Work with other IT (Information Technology) teams, security and business-related areas to keep abreast of the latest mobility requirements and policies.</li><li>Work with various wireless carriers, device manufacturers, software vendors to understand their strategies in providing enterprise mobility solutions.</li><li>Assist with developing and communicating new mobility services offerings and device standards.</li><li>Represent Mobility Infrastructure Services on various IT projects and business initiatives.</li><li>Work with Operations Support team, improve customer support and provide training where necessary.</li></ul>Requeriments:<ul><li>Must have Bachelor's degree (or U.S. equivalent) in Computer Science, Information Technology or a closely related field. Must have at least three (3) years of experience with MobileIron Mobile Device Management technology.</li><li>Must have at least three (3) years of experience in supporting server infrastructure technologies including technologies that rely on Apache, Linux, Windows & SQL systems; and in performing system engineering activities that will contribute to the successful delivery of Enterprise Mobility infrastructure solutions including application deployment, automation improvements, emerging technologies.</li><li>Must have three (3) years of experience working in a regulated environment within the pharmaceutical industry.</li><li>Must have working knowledge of mobile application development process and a solid understanding of mobile messaging, wireless networking and Active Directory technologies.</li><li>Ability to present on and/or speak to various mobility topics; excellent written communication and organizational skills; ability to work effectively with customers, vendors & technical staff at all levels; and ability to work effectively both independently and within a team also required.</li><li>40 hours per week: M-F: 9am-5pm.</li><li>Must have proof of legal authority to work in the US. </li></ul>Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): No Job Posting End Date:06/15/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R282076

Specialist, Business/Technology Analysis

Job Description Responsibilities: Primary: <ul><li>Carry out our mission by assuring finished goods and services are of the highest quality, optimal cost, and delivered on schedule</li><li>Function as a role model in our team-based Employee Involvement culture, focusing on continuous improvement of Wilson Operations</li><li>Operate and assist in trouble-shooting and problem resolution for processes and packaging equipment</li><li>Assist coaches and operators with operational, mechanical and technical activities that supports our production standards while following GMPs and SOPs</li><li>Conduct and train others in the cleaning and inspection of equipment between production batches</li><li>A Team Leader and trainer in the set up and adjust of production equipment, including tablet fillers, thermoforms, cappers, labelers, checkweighers, cartoners, casep, and palletizers, and other assemblies as appropriate, as needed for optimal performance within qualified parameters</li><li>Examine products to detect defects, product damage, or other visual quality problems</li><li>Assist coaches with managing the accuracy of critical information, and ensure the completion of required documentation for production processes are in order for optimal line performance</li><li>Identify, trouble-shoot, and offer resolution for equipment malfunctions and repair needs; communicate and manage appropriately with coach for timely resolution</li><li>Accurately manages areas to ensure the maintenance of detailed records as it relates to equipment cleaning, set-up, and challenge documentation</li><li>Assists coaches to ensure operational concerns are visible and solutions and/or continuous improvement actions are taken with an appropriate sense of urgency for appropriate resolution</li><li>Leads and contributes to the effectiveness of operations and implementation of viable continuous improvement initiatives</li><li>Leads the charge to ensure standard work areas are in a constant state of compliance with respect to proper housekeeping, material segregation, and personal gowning including required protective equipment</li><li>Demonstrates a strong mechanical aptitude and ability to troubleshoot and effectively communicate within noted time constraints </li><li>Supports off-shifts and weekend work as required</li></ul> Quality & Safety: <ul><li>Interacts with other departments - MMS and Quality to ensure all packaging operations are achieved in accordance with current Good Manufacturing Practices (cGMP), site Standard Operating Procedures (SOPs) and Divisional policies and guidelines</li><li>Identifies, raises, and assist with the management of quality issues</li><li>Troubleshoot and offer resolution and recommendation to coaches; appropriately gather and provide information for corrective actions</li><li>Works with coaches, Quality, Maintenance, and Planning to appropriately inform all parties of quality deviations; supports all investigations and corrective actions</li><li>Conducts and train others on line clearance activities thoroughly to prevent cross-contamination of products</li><li>Conforms to established safety procedures in accordance with OSHA and other regulatory agencies</li><li>Recognizes, utilize, and encourage others to use safety equipment</li><li>Champion for and actively takes accountability for personal safety as well as the safety of others</li><li>Identifies, reports, and documents unsafe conditions, participates in the investigation of accidents/injuries and corrective measures</li></ul> Equipment: <ul><li>Operates and train others to use packaging equipment within qualified parameters</li><li>Conducts and documents equipment challenges per current procedures</li><li>Demonstrates mechanical ability to troubleshoot, problem solve, and train others to recognize and solve equipment concerns as it relates to product jams and component problems</li><li>Identifies and communicate effectively, equipment problems to assist the mechanics with corrective repairs</li></ul> Financial: <ul><li>Understands and communicates requirements for achieving packaging Profit Plan standards</li><li>Assist coaches in communication of the production schedule to complete monthly orders</li><li>Contribute to achieving all departmental financial goals by understanding, communicating, and controlling labor tracking, component usage and material waste</li></ul> Team/Individual Performance: <ul><li>Actively assist coaches in leading a team-based culture through participation in team meetings and continuous improvement activities</li><li>Demonstrates a high degree of maturity, leadership, and personal integrity</li><li>Strictly adheres to all site policies on personal conduct and attendance</li><li>Collaborates and communications with peers and other employees at various levels throughout the organization | Demonstrates leadership and conflict-resolution ability</li><li>Demonstrates a willingness to provide and receive constructive feedback in 360&deg; performance review</li></ul> Education: <ul><li>H.S. Diploma or equivalent</li></ul> Experience and Skills: Required: <ul><li>Three to five years in a FDA regulated industry</li><li>Principled verbal and written communication skills</li><li>Work with others effectively, displaying strong interpersonal and organizational skills</li><li>Peer training activities</li></ul> Preferred: <ul><li>AAS degree or higher in Business, Science, or Technology</li><li>Yellow Belt certified or Kata training</li><li>Strong computer skills with experience using SAP</li><li>Understanding of Lean principles and Continuous Improvement acumen</li><li>Strong mechanical and technical skills</li></ul>NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: Hazardous Material(s): Job Posting End Date: 05/30/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/30/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R294737

Senior Operations Technician

Job Description Position Description: Operations Technician, Mechanical Essential Functions<ul><li>Operates automated and non-automated packaging equipment according to Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMPs)</li><li>Prepares packaging equipment for production according Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMPs)</li><li>First responder to challenges with packaging equipment</li><li>Conducts equipment set-up and dial on packaging equipment including but not limited to: product flow alignment, container size change adjustment, selection of correct qualified recipe parameters, set-up of qualified vision/inspection systems and verification of proper functionality of detection/rejection systems</li><li>Ensure all tasks are completed in a safe manner</li><li>Partners with maintenance personnel to reduce overall line downtime, and develop a deeper operational knowledge of equipment</li></ul>Automated and Non-Automated Packaging Equipment | SOPs and GMPs<ul><li>Load packaging material into process flow</li><li>Move packaging material to different locations on the packaging line</li><li>Inspect material rejected from equipment for defects prior to repackaging and properly handle waste material which cannot be repackaged according to regulation and law</li><li>Utilizing TrackSys data, trend and escalate equipment performance issues to maintenance and reliability teams</li><li>Document activities within applicable batch documentation</li><li>Clear/Clean packaging equipment</li><li>Inspect packaging equipment post cleaning</li><li>Setup and Adjust the equipment</li><li>Use appropriate tools</li><li>Ensure Proper Alignment | Clearances</li><li>Partners with maintenance personnel to assist with non-routine equipment repairs, including helping with repairs under guidance of maintenance, initiating work orders and retrieving parts from the stockroom</li><li>Provides assistance to maintenance personnel that are executing PMs in order to develop a better operational understanding of the equipment functionality</li></ul>First Responder to Packaging Equipment Challenges<ul><li>Determine if the challenge is due to the equipment or the component being run on the equipment</li><li>Gather/Document key information at time of the challenge to aide in current and if necessary, future trouble shooting activities</li><li>Make minor equipment adjustments as needed to return the equipment to a functional state</li><li>Document activities using the computerized maintenance management system</li><li>Use technical manuals for troubleshooting/verification of proper set-up and functionality</li><li>Leverage vendor training when troubleshooting</li><li>Escalate to Maintenance when the challenge/issue has not been resolved within the expected timeframe or requires modification of control systems, electrical troubleshooting, advanced troubleshooting or significant equipment failure has occurred.</li></ul>Safety<ul><li>Follow established safety standards while following SOPs and GMPs</li><li>Actively take accountability for personal safety as well as the safety of others</li><li>Identify, report, and document unsafe conditions</li><li>Recognize and utilize safety equipment when needed</li></ul> Position Qualifications: Education Minimum Requirement: <ul><li>High School diploma or equivalent (GED)</li></ul>Required Experience and Skills:<ul><li>One (1)+ year of previous production or warehouse experience</li><li>Ability and willingness to learn manufacturing procedures and federal regulations pertaining to manufacturing processes</li><li>Demonstrated ability to read and interpret documents such as safety and environmental policies, operating and maintenance instructions and procedure manuals, etc</li><li>Ability to read and understand customer specifications, cGMP's and SOP's</li><li>Strong record keeping skills</li><li>Excellent verbal and written communication and skills</li><li>Ability to work independently and collaboratively, as required, in a fast paced, matrixed, team environment</li><li>Analytical thinking with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines</li><li>Must be able to troubleshoot problems and report issues</li><li>Must understand and follow all plant safety guidelines</li><li>Individual may be required to site, stand, walk regularly</li><li>Ability and willingness to work additional hours as required by business needs</li></ul>Preferred Education, Experience and Skills:<ul><li>Associates Degree</li><li>Lock-out-tag-out (LOTO)</li></ul>Shift and Schedule:<ul><li>1st shift, Monday to Friday</li><li>Work overtime on weekends</li></ul>MSJR NOTICEFORINTERNALAPPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 05/30/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/30/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R294800

Operations Technician, Mechanical

Job Description This role will support Manufacturing Operations and will serve as the primary Quality Assurance representative for the Elkhorn site's Frozen Vial Management, serving as the site Subject Matter Expert (SME) in all aspects of Frozen Vial Management. This team member will provide guidance to the Elkhorn site around the quality and compliance of Frozen Vial Management; thus, they will need to have knowledge of local and global Animal Health standards, USDA regulations, and cGMP's. Typical job duties for this position include, conducting investigations into vial discrepancies, maintaining complete and accurate frozen vial records, leading Elkhorn site projects to ensure further compliance with external requirements, release of new frozen vial lots of material, ensuring that new lots are made in compliance of applicable government regulations and keeping the Quality Assurance SOP's aligned to regional and global procedures. Additionally, this role will serve as the back-up for staging frozen vial inventory for operations, inventory counts of QA freezers, shipping frozen vials to different sites, and responding to off-hours issues with freezers. The Quality Assurance Specialist will be instrumental in the operations of the Elkhorn Manufacturing Facility. They will conduct annual inspections within the various site departments while assisting in prioritization and execution of Quality Compliance actions assigned to the site. Additionally, this role will be occasionally assigned short term tasks and projects with varying degrees of urgency and difficulty and thus organization, critical thinking and creativity are necessary attributes for this role. A successful candidate will navigate the various perspectives of Planning, QA and Production utilizing Leadership Behaviors and principals of Inclusion, while holding Safety and Quality as primary values. Additional duties will include the following: <ul><li>Perform high level functions in SAP.</li><li>Participation in Annual Outline Review.</li><li>Key participant in Quality Compliance Inspections from off-site entities.</li><li>Other tasks as assigned by QA Manager and Quality Director.</li></ul>Education Minimum Requirement: <ul><li>Bachelor's Degree (degree in the sciences preferred)</li></ul>Required Experience and Skills: <ul><li>Minimum of two years of experience in a regulated industry.</li><li>Strong written and verbal communication skills.</li><li>Experience with investigations and risk assessments</li><li>Knowledge and understanding of Frozen Vial Inventory Management</li></ul>Preferred Experience and Skills:<ul><li>Familiarity and/or experience with vaccine manufacturing and/or testing.</li><li>Basic knowledge of USDA regulations and inspections</li><li>Project Management experience.</li><li>Candidates have experience in SAP, Aera and Reliance or similar systems.</li></ul> NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 05/27/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/27/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R295894

Quality Assurance Specialist

Job Description Our Scientists are our Inventors. We deliver robust scientific data and interpretation that drives the commercialization of breakthrough therapeutics using innovative thinking, state-of-the-art facilities, and modern equipment. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity, and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement, and teamwork. As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing your career. The Analytical Research and Development, Cell Based Sciences Department in West Point, PA is seeking a motivated Principal Scientist with technical expertise in developing large molecule potency assays. More specifically, the ideal candidate will be a recognized expert developing mechanism-of-action reflective potency assays for the development of multi-valent recombinant vaccine products. The Vaccine Potency team is a laboratory-based scientific and technical group tasked with solving complex analytical problems at the interface of biology, chemistry, and lab informatics disciplines to enable development of Vaccine clinical candidates. The successful candidate is expected to provide scientific leadership, expertise, and creativity to solve complex project problems across the large molecule portfolio. They will be accountable to inspire and sponsor scientific evaluation and implementation of innovative and disruptive technologies and approaches. Responsibilities include representing the group on product development teams and defining the potency strategy for a portion of our large molecule portfolio, oversight of method development and testing, and scientific mentoring. The candidate will be expected to effectively communicate with stakeholders in partner organization and to management and governance teams. Education Requirements: <ul><li>Ph.D. in analytical chemistry, molecular biology, cell biology, virology, or related field with a minimum of 8 years of relevant experience</li><li>OR M.S. with a minimum of 10 years of relevant experience</li><li>OR Bachelor's with a minimum of 14 years of relevant experience</li></ul> Required Skills and Experience: <ul><li>In-depth knowledge and understanding of immunoassay development including antigen and antibody selection, antibody matched pair screening and optimization, binding kinetics, and multiplexing.</li><li>Expertise in cell biology and immunology, with application to solve complex scientific challenges related to designing and developing GxP potency assays to support a variety of vaccine modalities.</li><li>Demonstrated ability to lead complex experimental design and detailed data analysis concepts related to analytical method development.</li><li>Deep working knowledge of regulatory guidance and quality standards, with experience authoring and reviewing regulatory submissions and responses (biologics license application submission) and interacting with Health Authorities.</li><li>Ability to excel in a team-based environment, partnering and influencing in a professional and positive manner.</li><li>External scientific engagement demonstrated through publications, regulatory guidance documents, industry white paper contributions, presentations at scientific meetings, and/or membership on (or leading) cross-company working groups or consortia.</li><li>Excellent verbal and written communications skills.</li></ul>#AR&D #EligibleforERP NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 06/30/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:06/30/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R295603

Principal Scientist, Analytical Research and Development

Job Description Our company's Research Labs Discovery Neuroscience group based in West Point, PA, is seeking a motivated scientist with a deep understanding of the neurobiology of pain pathway and competency to use a multidisciplinary approach to join a highly collaborative team of scientists working on discovering and developing the next generation of therapies to treat pain and other neurological diseases. Responsibilities include but are not limited to:<ul><li>Participate (scientific and from the bench) in new and ongoing target identification and validation efforts related to treating pain.</li><li>Design and perform histology experiments (including immunohistochemistry and in situ hybridization- RNAscope) on preclinical and patient tissues.</li><li>Participate in managing the department's core histology laboratory including training colleagues on available immunostaining and imaging platforms and assisting in histology work across the broader neuroscience department, as needed.</li><li>Conduct animal behavioral studies and/or neurophysiology experiments (in vivo/ slice electrophysiology) to drive the discovery process.</li><li>Perform data analyses, interpretation and presentation of results at department level and in cross functional program teams.</li><li>Contribute to a safe and compliant laboratory work environment.</li></ul>Education Minimum Requirement: <ul><li>PhD in Pharmacology/Physiology/Neuroscience with 2 years of Postdoctoral Experience</li><li>Or MS in Pharmacology/Physiology/Neuroscience with 5 years of pharma/biotech experience.</li></ul>Required Experience and Skills: <ul><li>Skilled in performing histochemistry techniques such as immunofluorescence, RNAscope</li><li>Proficiency in using automated immunostaining platforms such as the BOND and/or high throughput image analyses platform like the HALO</li><li>Experience with performing animal behavioral studies/familiarity with behavior pain models</li><li>Skilled in performing ex vivo or in vivo electrophysiology recordings and data analysis</li><li>Demonstrated ability to conceive, design, execute and communicate complex physiology/pharmacology experiments as evidenced by publications</li><li>Demonstrated ability to work independently, be self-motivated and collaborative</li></ul>Preferred Experience and Skills: <ul><li>Experience with performing animal surgeries</li><li>Experience with in vitro and/or in vivo calcium imaging technique</li><li>Willingness to work with Non-Human Primates (NHPs)</li></ul>NOTICEFORINTERNALAPPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 05/25/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/25/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R296071

Senior Scientist- Pain Neurobiologist/Neuroscientist

Job Description Job Description: The West Point PV (Polysaccharide Vaccine) organization is seeking a highly motivated Senior Specialist within the PV E2E Tech Ops Projects team. The successful candidate will have the opportunity to contribute to the performance and results of the manufacturing area by providing engineering/technical guidance and support for process, equipment, facility and analytical projects of varying complexity and size, including strategic site and network-wide initiatives. Primary Responsibilities: <ul><li>Leads, Supports, and/or executes process, equipment, and facility projects for the PV E2E.</li><li>Leads, Supports, and/or executes continuous improvement projects that increase compliance, reduce cost, and/or simplify/standardize the process. </li><li>Examines complex issues from diverse perspectives (safety, compliance, automation, validation, equipment, process, and people) to best understand and resolve the root cause.</li><li>Designs, authors, updates, and/or reviews and approves engineering, technical, and manufacturing documents (change control, validation documents, commissioning documents, etc.) necessary for engineering studies and project execution in a Good Manufacturing Practice environment.</li><li>Provides on-the-floor support for project implementation and studies, as required.</li><li>Leads or participates in Quality Risk Assessments.</li><li>Supports team safety, environmental, and compliance objectives.</li><li>Manages project timelines to ensure key compliance and customer due dates are met; escalates any potential delays and develops remediation plans when possible.</li><li>Collaborates effectively with Operations, Quality, Planning, project teams, and external vendors, anticipating and interpreting customer needs to identify and implement solutions.</li><li>Supports regulatory inspection activities.</li></ul> Education Minimum Requirement: <ul><li>B.S. Degree in Engineering or other equivalent technical fields.</li></ul> Required Experience and Skills: <ul><li>Minimum five (5) years' post-bachelors degree experience in a GMP functional area/manufacturing environment or support of a GMP functional area, such as Operations, Technical Operations, Technology, Engineering, and/or Maintenance; OR</li><li>Master's and 3 years of experience</li><li>Experience in deviation management and/or change control and/or equipment support and/or project support role.</li><li>Highly developed communication, leadership, and teamwork skills.</li><li>Ability to manage projects/work to schedule/deadlines.</li><li> Pharmaceutical/Biopharmaceutical experience</li></ul> Preferred Experience and Skills: <ul><li>Interested candidates must be capable of providing boundaryless application of leadership skills for project management and global change management while staying aligned with changing requirements and continuously identifying opportunities to improve the processes and support to our customers.</li><li>Experience in biologics, vaccine, or bulk sterile manufacturing facilities</li><li>Change Control author</li><li>Project Management</li><li>Six Sigma training</li></ul>NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 06/5/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:06/05/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R296179

Job Description The Biologics Analytical Research & Development department of our Research Laboratory Division is seeking applicants for an Associate Principal Scientist position within the Automation group, available at its Rahway, New Jersey research facility. The Associate Principal Scientist is a laboratory-based scientific role tasked with identifying, developing and deploying automation and high throughput tools and techniques in support of the Biologics AR&D and the broader analytical organization. The successful candidate must function well and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment. Then, independently or as part of a team, work to develop and implement automated solutions. The candidate is expected to be self-motivated and possess excellent communications skills in order to drive adoption of automated workflows and effectively communicate results through reports and presentations to key stakeholders and to the external scientific community through presentations and publications. Experience developing and implementing automated and/or high throughput liquid-handling workflows while also mentoring others will aid in distinguishing candidates. Evidence of strong cross-functional collaboration in an academic or industrial setting and a working knowledge of Good Practices (GxP) as it relates to experimental execution and documentation is desired. Education Minimum Requirements: <ul><li> A Ph.D. with 4 years of experience, a Master's degree with a minimum of 8 years of experience, or a Bachelor's degree with a minimum of 12 years of experience in analytical chemistry, biochemistry, organic chemistry, engineering or other pharmaceutically related field with a focus on automation-centric work. </li></ul> Required Experience and Skills: <ul><li> Experience developing and implementing automated liquid handling platforms for parallel experimentation </li><li> Experience in analysis of biologics or other pharmaceutically relevant entities using separation or plate-based techniques (capillary electrophoresis, IEX, iCIEF, SEC, glycan analysis, ELISA, etc) </li><li> Demonstrated ability for taking initiative, creativity and innovation in problem solving </li><li> A strong team player with excellent oral and written and communication skills with the ability to work independently to develop and design experiments, critically evaluate data, and then iterate as part of the scientific method </li><li> Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment </li></ul> Preferred Experience and Skills: <ul><li> Experience in data analytics or programming </li><li> Background in the development of new methods and sound scientific understanding of Quality by Design (QbD) and Design of Experiments (DOE) principles as well as data analysis and statistics </li><li> Working knowledge of Regulatory Good Practices (GxP) with regards to laboratory experimentation and documentation </li><li> Experience with performing gap analyses in order to identify problems, development solutions, and implement them in a laboratory environment. </li></ul>#AR&D # EligibleforERP NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $135,500.00 - $213,400.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 06/28/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:06/28/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R296139

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