Specialist, Validation Engineer

Validation Engineer

Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

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.

Key Responsibilities:

• 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 & Experience:

• 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.

Compensation Overview: Devens - MA - US: $87,010 - $105,431. The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may vary based on the job and location.