Senior Specialist, Validation Engineer II

Bristol Myers Squibb • Devens, MA

8d • $92,540 - $112,136

About The Position

The Senior Specialist, Validation Engineer II supports implementation of manufacturing and laboratory equipment, facilities, and utilities at multi-use sites in coordination with internal customers and external service providers. The role qualifies new equipment, facilities, and utilities and maintains equipment systems in a qualified or validated state in accordance with established policies and procedures. Work includes projects and ongoing activities of low to moderate complexity, performed with minimum supervision and general instructions.

The position prepares and executes validation and qualification documentation and activities across the validation lifecycle, supports equipment qualification and validation, and helps ensure periodic reviews and requalification are completed on schedule. It provides technical guidance and customer support, contributes validation expertise to multifunctional teams, and supports alignment with company directives and industry guidelines. The incumbent may serve as a subject matter expert during internal and regulatory audits and contributes to regulatory inspection readiness.

Requirements

• Bachelor of Science in Chemical Engineering, Mechanical Engineering, a related discipline, or equivalent engineering education.
• At least 3 years of relevant experience with process equipment, computer systems, manufacturing process control systems (automation), and laboratory instrumentation in an FDA-regulated manufacturing facility.
• At least 2 years of experience in equipment, facility, or utility qualification.
• Familiarity with cGMP in the pharmaceutical industry.
• Working knowledge of SOPs, cGMPs, compliance requirements, and FDA and EU regulatory guidelines, including experience establishing validation philosophies and regulations at a site level.
• Understanding of investigations, deviations, and CAPA management in a regulated pharmaceutical industry.
• Strong problem-solving, verbal and written communication, interpersonal, and technical writing skills.
• Ability to work independently, manage multiple priorities, and meet project team goals and timelines.
• Ability to represent the department professionally and technically before customers, regulatory agencies, and management.
• Ability to handle difficult and unusual tasks using creative problem-solving.
• Ability to understand business needs and develop solutions across functions.
• Team orientation, individual initiative, accountability, and professional maturity.

Nice To Haves

• Direct experience with equipment, facility, and sterilization commissioning and qualification, critical utilities validation, and temperature mapping concepts.
• Knowledge of distributed control systems and automation (GAMP) validation concepts.
• Knowledge of designing and implementing quality systems and validation program elements for the validation lifecycle of a fully automated, multi-product biologics or cell therapy manufacturing facility.
• Familiarity with FDA, EMA, and worldwide regulatory validation requirements, including ICH Q7, Q8, and Q9, particularly for biologics or cell therapy manufacturing.
• Working understanding of lean principles and Six Sigma processes.
• Demonstrated proficiency in project management, communication, and technical writing.

Responsibilities

• Develop and execute validation and qualification deliverables, including validation plans, requirements specifications, traceability matrices, and summary reports.
• Ensure periodic reviews and requalification are performed according to schedule.
• Support equipment qualification and validation activities.
• Develop qualification protocols and associated reports while following the change management process.
• Author and review SOPs, work practices, test protocols, validation deliverables, plans, and policies as needed.
• Execute validation lifecycle maintenance, including establishing validation document hierarchies, tracking work arising from change controls, managing shutdowns and changeovers related to validation, and managing revalidation and cleaning monitoring programs when necessary.
• Execute work arising from change strategy, risk assessment, testing, and compliance gaps.
• Execute limited-scope and complex validation projects under strict deadlines to support stakeholders and bulk drug supply.
• Maintain familiarity with BMS directives and industry guidelines on qualification and validation.
• Provide customer service and support, review and prioritize equipment qualification and support requests, and respond promptly.
• Provide technical support and guidance on qualification and validation issues and interface with customers to ensure expectations are met.
• Maintain positive relationships with team members and site customers and promote a positive team environment.
• Contribute to multifunctional teams as the validation representative.
• Ensure alignment with BMS directives and industry guidelines on validation and quality engineering.
• Serve as a subject matter expert in internal and regulatory audits when called upon.
• Contribute to preparation for regulatory inspection readiness.
• Perform other duties as assigned.

Benefits

• Comprehensive benefits, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings.
• Flexible Time Off for eligible U.S.-based exempt employees, subject to manager approval.
• Paid vacation for eligible non-exempt employees, RayzeBio employees, and employees located in Puerto Rico.
• 11 paid company holidays annually.
• Three optional holidays for eligible non-exempt employees, RayzeBio employees, and employees located in Puerto Rico.
• Depending on eligibility, paid sick leave, up to two paid volunteer days per year, summer-hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs.
• Annual Global Shutdown between Christmas Day and New Year's Day for eligible employees.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior