Senior Specialist, Operations
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.
This high impact role in our Company Manufacturing assures that products manufactured comply with cGMPs, operating procedures and other applicable regulations. The support focuses on management of the shop floor compliance and implementation of lean manufacturing initiatives aligned with department goals. The Senior Specialist, Operations and Engineering, will be responsible for support of production of Live Virus vaccines and a new vaccine product for clinical supply within Building 29. This engineer will be a member of the Lyo operations management team in the Live Virus Vaccine Manufacturing End-to-End at the West Point site. The primary responsibility of the individual will be to help facilitate day to day production, be a team lead for operations and support groups, manage staffing and training of new USW and salary employees, in support of formulation and final product filling operations. Support will be focused on the Operations and Production Management process including operations support, equipment troubleshooting, implementation and development of new processes/ equipment actions, continuous improvement of current Lyo processes, and other related duties. This position will require development of technical expertise of corresponding IPT operations and mentorship/development of more junior members of the team. Limited off-shift or weekend coverage may be required based on business unit needs and specific assignments.
Additional responsibilities include the following:
Supports the managers in the direct processing of materials to ensure attainment of business results.
Develops an in-depth knowledge of the equipment and process.
Builds knowledge of the company, process, clients and/or customers.
Manage conflict and effect resolution of technical and personal challenges using standard procedures is key as is openness to change and the ability to effect positive change.
Leads and/or works as a team member on manufacturing investigations and/or process improvement projects.
Has ability to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.
Applies team effectiveness skills, listening and integrating diverse perspectives from across the work group.
Assures consistent application of standardized work, engineering and process tools.
Provides technical support to manufacturing shop floor for problems and issues.
Conducts and assists in the design of experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale.
Provides technical guidance to staff, colleagues or customers as well as anticipates and interprets the customer needs to identify solutions. May be responsible for presenting technical discussions to regulatory agencies during inspections.
Contributes and adds value to the achievement of team goals
Ensure compliance with safety and environmental practices, cGMPs and Standard Operating Procedures in the work area.
Demonstrate integrity, credibility, and flexibility in their daily performance so as to motivate others to do the same.
Perform a thorough review of batch records and related GMP documentation, identifying and resolving discrepancies in a timely manner and implementing corrective actions to improve the batch record execution/review process.
Work with subject matter experts provide/track necessary training for operator qualification as assigned.
Participate in the design and implementation of training and development programs and training materials.
Foster a collaborative relationship with manufacturing floor personnel focused on high quality investigations, meaningful corrective actions and reducing the deviation generation rate.
Determines/implements appropriate and effective corrective and/or preventative actions to prevent reoccurrence of deviations and ensure they improve the Right First Time metrics.
Identifies and solves a range of problems in straightforward situations; analyzes possible solutions and assesses each using standard procedures.
Makes decisions that are guided by site policies and procedures.
Collaborates with supporting departments such as Quality, Tech Ops and Maintenance to solve problems in an efficient and compliant manner.
Consults with manager on more complex decisions and issues that impact other departments.
Accountable for contribution to project team or sub-team, may manage/led a small project team.
Collaborates with team members in the identification and implementation of continuous improvement initiatives and action plans.
Supports activities in the areas of cost containment, efficiency, productivity, energy conservation, waste minimization, operational excellence, and lean practices.
Aware of costs and assists in controlling costs related to own work.
This position will require weekend work due to the nature of biological processes.
Education Minimum Requirement:
B.S. degree in Engineering or Sciences.
Required Experience and Skills:
Previous experience is required in one of the following areas: Pharmaceutical Manufacturing, Commercial Manufacturing, Personnel Management, Deviation Management
Minimum of 3 years relevant work experience, including direct support of development or manufacturing of biologics / sterile products (or M.S. degree with 2 year of experience).
Demonstrated leadership and ability to drive results
Strong communication, collaboration skills and ability to drive accountability
Demonstrates strong problem-solving skills and a hands on approach to problem solving.
Ability to work independently.
Willingness to work off-shift and weekends
Preferred Experience and Skills
Participation in regulatory inspections
Experience with formal problem-solving techniques, such as root cause analysis (RCA), failure mode effects analysis and/or Lean Six Sigma Tools.
Manufacturing plant experience in operational capacity
Experience working in a Union environment
Experience working in SAP or other Enterprise Software
Knowledge of Code of Federal Regulations.
Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.
Who we are …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
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Shift:1st - Day
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