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Job Details


Bristol-Meyers Squibb, Co.

Validation Engineer

Pharmaceuticals

All

Full Time

On Site

No

Devens, Massachusetts, United States

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Responsible for implementing the design, implementation and maintenance of a robust validation lifecycle for process equipment, SIP/CIP processes, critical process equipment & utility systems, process automation systems and manufacturing execution system recipes, computer systems, and laboratory instrumentation. Implement validation philosophies and master plans required to drive the validation lifecycle of a fully automated biologics manufacturing facility. Responsibilities include oversight of validation lifecycle maintenance that includes establishment of validation document hierarchy, tracking execution work arising from change controls, shutdown/changeover management related to validation, and management of the revalidation and cleaning monitoring programs. Responsible to contribute in the preparation for regulatory inspection readiness. Work collaboratively with peers within the Validation Execution function, Manufacturing Systems, Information Technology, Manufacturing, Manufacturing Engineering and Quality Effectively manage workload to address priorities, meet schedules, maximize productivity, reduce costs, and increase efficiencies. Ensure alignment with BMS directives and industry guidelines on validation and quality engineering. Execute validation work arising from change controls, capital projects, shutdown/changeover activity, and ongoing validation lifecycle programs. This individual works at the highest level and collaborates with Quality Assurance, to establish appropriate, risk-based validation methodologies. Contributes to multi-function teams, representing validation.

Qualifications

Knowledge of Engineering and Quality Assurance generally attained through studies resulting in a B.S., in engineering, a related discipline, or its equivalent and applicable industry experience A minimum of 4 years relevant experience in a Validation role in the biopharmaceutical industry or its equivalent. Knowledge process equipment and system qualification, sterilization qualification, critical utilities validation, cleaning validation, and temperature mapping is required.

Experience in designing and implementing quality systems and validation program elements required to manage the validation lifecycle of a fully automated, multi-product, biologics manufacturing facility. Knowledge in establishing site and program validation strategies that are aligned with current industry mindsets. Understanding of lean principles and establishment of effective process metrics is preferred. Project management, communication, and technical writing skills are required. Possess the professionalism and technical competency required to represent the department before our stakeholders, and management. Understanding of SOPs, cGMPs and compliance requirements and regulatory guidelines (FDA, EU) and the technical acumen to work and manage within a regulatory environment. Knowledge of regulatory validation requirements including FDA, EMA and all other Worldwide Regulatory requirements (ICH Q7, Q8, and Q9) particularly as it applies to biologics manufacturing. Understands business needs and synthesizes solutions across functions. Demonstrated emotional intelligence required to inspire and influence the behaviors and performance of others. The flexibility required to constructively lead and encourage peers and team members to drive results in a changing environment.

Work both independently and in a team environment at all levels of the organization, in particular Quality, Engineering and Manufacturing Operations.

Work within all Site Facilities, including laboratory settings, which requires one to give a high attention to detail and on occasion to properly use Personal Protective Equipment (PPE).

Exercises sound judgment in making decisions and recommendations within generally defined practices and policies with little guidance, notifying management when necessary. Typically makes recommendations to Manager, but does not make final decisions. May work on assignments that are extremely complex in nature where independent action and a high degree of initiative are required in resolving problems and developing recommendations. Becomes actively involved as required to meet schedules or resolve problems. Erroneous decisions or failure to achieve results may have financial implications or cause delays in schedules.

Incumbent performs all standard tasks completely and independently (often in line with Sr. Validation Engineer/Manager suggestion) to determine methods and procedures on new assignments. Receives assignments in the form of objectives and establishes goals to meet objectives. Work is reviewed and measured based on meeting established objectives and schedules. Only unusual or difficult tasks require supervisory review of anything other than final results.

#LI-Onsite

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to . Visit[Register to View] target="_blank"> [Register to View] to access our complete Equal Employment Opportunity statement.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.