Manager Engineering Commissioning Qualification & Validation

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Position Summary

BMS Cruiserath Biologics is seeking to recruit a Manager, Engineering CQV – Facility & Process Utilities on a fixed-term contract basis. This role is part of the Engineering CQV team and operates under a campus approach, with responsibility for the qualification and validation of critical facility and process utilities, including HVAC systems, across both the Multi-Product Cell Culture (MPCC) and Sterile Drug Product Facility (SDPF) sites. The role reports to the Sr. Manager, Engineering CQV, and is focused on:

- Commissioning, qualification, and lifecycle requalification of critical process utilities (WFI, purified water, clean steam, compressed air and gases, CIP/SIP systems) across MPCC and SDPF.
- Commissioning, qualification, and ongoing performance verification of facility utilities, including HVAC systems

The manager will develop and implement qualification strategies for facility and process utilities, including HVAC systems, and drive continuous improvement initiatives to enhance the efficiency, compliance, and effectiveness of CQV operations across both facilities.

Role Overview

Manager, Engineering CQV: Facility & Process Utilities
This role is responsible for leading all commissioning, qualification (IQ, OQ, PQ), and requalification activities for critical facility and process utilities across the MPCC and SDPF facilities, including WFI and purified water systems, clean steam, compressed air and process gases, CIP/SIP skids, HVAC systems and cleanrooms, and Building/Environmental Monitoring Systems (BMS/EMS). The manager will develop and implement utilities qualification strategies, oversee commissioning and start-up activities, manage a team of Facility & Process Utilities Qualification Senior Specialists, and ensure all qualification work is executed in compliance with FDA, EMA, and GMP requirements. The role will interface with MS&T, Manufacturing, Facilities, and Engineering teams across both sites to ensure qualification readiness and operational handover.

Key Responsibilities

- Operating under a campus approach across the MPCC and SDPF facilities, and reporting progress and escalations to the Sr. Manager, Engineering CQV.
- Plan, coordinate, and oversee commissioning, qualification, and requalification activities for facility and process utilities across both sites, ensuring timely completion and adherence to budget.
- Develop and implement utilities qualification strategies, master plans, and risk-based approaches (ASTM E2500, ISPE Baseline Guide Vol. 5) aligned with current regulatory expectations for both MPCC and SDPF.
- Ensure compliance with applicable regulatory requirements (FDA, EMA, ICH, GMP) and internal quality standards and procedures for facility and process utilities.
- Conduct and review risk assessments for facility and process utilities; develop and implement mitigation strategies.
- Author, review, and approve URS, DQ, IQ/OQ/PQ protocols and reports, requalification plans, and SOPs for facility and process utilities, ensuring accuracy, completeness, and regulatory compliance.
- Collaborate with cross-functional teams including Facilities, Engineering, Quality Assurance, Regulatory Affairs, and Manufacturing across both facilities to align utilities qualification activities with overall project and operational objectives.
- Develop and implement change control processes, ensuring modifications to utilities, HVAC systems, and cleanroom environments are properly validated and documented across both sites.
- Identify and implement process improvement and optimisation opportunities across utilities CQV activities on campus, including energy and performance efficiencies.
- Collaborate with external vendors and contractors to ensure proper installation, qualification, and validation of utilities equipment and systems (including HVAC), including review and approval of vendor documentation.
- Oversee environmental monitoring qualification, cleanroom classification, and temperature/humidity mapping studies supporting both facilities.
- Provide training, mentorship, and performance management to validation team members to support professional growth and development.
- Support internal and external audits and inspections related to utilities CQV activities across the campus; address findings and implement corrective actions as required.

Qualifications & Experience

- Bachelor's or Master's degree in Mechanical Engineering, Process Engineering, Life Sciences, or a related discipline.
- Experience in Commissioning, Qualification, and Validation (IQ/OQ/PQ) of critical facility and process utilities, including HVAC systems, within a GMP-regulated biologics or pharmaceutical environment.
- Experience developing and implementing utilities qualification strategies and managing qualification projects from concept through to lifecycle closure.
- Strong understanding of regulatory requirements (FDA, EMA, ICH) and industry standards - Experience conducting risk assessments and developing mitigation strategies in a GMP environment.
- Proficiency in preparing and reviewing qualification protocols, reports, and SOPs; excellent technical writing skills are essential.
- Proven ability to collaborate with cross-functional teams and manage multiple stakeholders across a multi-facility campus environment.
- Demonstrated track record of driving process improvement and compliance optimisation.
- Experience supporting health authority inspections and internal audits, including responding to observations and implementing CAPAs.
- Previous experience with a biologics facility and familiarity with HVAC

Why you should apply

• You will help patients in their fight against serious diseases
• You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
• You’ll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical allowance, 27 days of annual leave, life assurance and on-site gym

#LI-Onsite

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

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

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R1608492 : Manager, Engineering Commissioning Qualification & Validation