Senior Manager, Commissioning Engineering
About The Position
The Senior Manager, Commissioning Engineering is part of the Validation team and reports to the Associate Director, Validation Engineering. The role supports Bristol Myers Squibb’s clinical and commercial manufacturing facility in Devens and may lead contractors overseeing complete asset life-cycle onboarding, commissioning, and other work arising from the design and implementation of new or modified assets in capital projects. The role applies engineering project management knowledge to support multiple fast-paced projects across functions during commissioning and asset introduction or modification. The position organizes and completes commissioning program documents and deliverable templates in accordance with BMS project practices and GMP qualification policies. It also manages contractors and vendors, schedules vendor qualification and factory acceptance testing, and assists with onboarding assets to the site cMMS system. The role leads commissioning, vendor installation, and operational and performance qualification activities; oversees commissioning protocols, execution, and reports; and coordinates with project engineering and support departments to ensure systems are ready for installation, start-up, qualification, or use. The manager oversees multiple capital execution projects, resources, and a high-performance commissioning team, while ensuring alignment with BMS directives and industry guidelines.
Requirements
- At least 6 years of relevant experience with process equipment, computer systems, manufacturing process control systems (automation), and laboratory instrumentation in an FDA-regulated manufacturing facility.
- Bachelor of Science degree in Chemical Engineering, Mechanical Engineering, a related discipline, or equivalent.
- Ability to execute smaller, complex technical projects.
- Demonstrated effectiveness working both in a team environment and as an individual contributor.
- Excellent project management, communication, and technical writing skills.
- Ability to handle multiple priorities and meet project team goals and timelines.
- Professionalism and technical competency to represent the department to customers, regulatory agencies, and management.
- Demonstrated understanding of engineering documentation, including P&IDs, process flow diagrams, and standard operating procedures.
- Proven ability to work in a matrix environment and lead multilevel, cross-functional teams to achieve site and departmental objectives.
Nice To Haves
- Direct experience with equipment, facility, and sterilization commissioning and qualification, critical utilities validation, and temperature mapping concepts.
- Previous managerial experience demonstrating proficiency in selecting, motivating, and retaining a strong team; managing personnel issues; and planning and administering financial resources.
- Working understanding of lean principles.
- Master’s or graduate degree in a technical discipline.
Responsibilities
- Lead functions responsible for commissioning, vendor installation, and operational and performance qualification of systems arising from projects.
- Draft or oversee commissioning protocols, execute commissioning activities, and write commissioning reports.
- Work with vendors and project engineering to prepare systems for installation and start-up testing.
- Coordinate with Digital Plant, Facilities, Metrology, and Maintenance to ensure systems are installed appropriately and ready for qualification or released to system owners for use.
- Manage multiple projects and serve as a point of contact for capital execution projects.
- Partner with project managers to prioritize projects, track milestones and deliverables, and provide regular status updates to site management.
- Collaborate with Engineering, Digital Plant, Manufacturing, and Quality.
- Manage assigned resources to address priorities, meet schedules, maximize productivity, reduce costs, and improve efficiency.
- Ensure commissioning activities align with BMS directives and industry guidelines.
- Develop and lead a high-performance commissioning team; recruit and develop staff, coach and mentor employees, provide development opportunities, and administer rewards and recognition.
- Establish and communicate performance standards, define accountability, and lead continuous improvement strategies.
- Manage contractors and vendor qualification, schedule vendor qualification and factory acceptance testing, and assist with asset onboarding to the site cMMS system.
- Perform other duties as assigned by the Commissioning Head.
Benefits
- Wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings, subject to applicable plan terms and eligibility.
- Flexible Time Off without a set accrual limit for eligible U.S.-based exempt employees, subject to manager approval.
- 11 paid company holidays annually for eligible employees.
- For specified non-exempt, RayzeBio, and Puerto Rico employees: 160 hours of paid vacation annually for new hires, subject to manager approval, 11 paid company holidays, and 3 optional holidays.
- 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.
- Eligible employees may receive an annual Global Shutdown between Christmas Day and New Year’s Day.
- Potential eligibility for discretionary incentive cash and stock opportunities.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
