Manager, Senior Engineer Engineering Commissioning, Qualification & Validation
- Full Time
About the role
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 Commissioning, Qualification and Validation (CQV) – Equipment Qualification / Requalifications. This is a 12 month fixed -term contract role.
The role is part of the Engineering CQV team and operates under a campus approach, with responsibility for equipment qualification and requalification activities across both the Multi-Product Cell Culture (MPCC) and Sterile Drug Product Facility (SDPF) sites. The role reports to the Sr. Manager, Engineering CQV.
The manager will develop and implement equipment qualification and requalification strategies, and drive continuous improvement initiatives to enhance the efficiency, compliance, and effectiveness of CQV operations across both facilities.
Role Overview
This role is responsible for leading equipment qualification and requalification activities (IQ, OQ, PQ) across the MPCC and SDPF facilities. The manager will develop and implement equipment qualification and requalification strategies, oversee commissioning and start-up activities, manage a team of Equipment Qualification Senior Specialists, and ensure all qualification work is executed in compliance with FDA, EMA, and GMP requirements. The role will interface with Manufacturing, 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 equipment commissioning, qualification (IQ/OQ/PQ), and requalification activities across both sites, ensuring timely completion and adherence to budget.
- Develop and implement equipment qualification and requalification strategies, master plans, and risk-based approaches aligned with current regulatory expectations for both MPCC and SDPF.
- Manage the periodic requalification programme to maintain the qualified state of equipment throughout its lifecycle.
- Ensure compliance with applicable regulatory requirements (FDA, EMA, ICH, GMP) and internal quality standards and procedures.
- Conduct and review risk assessments; develop and implement mitigation strategies.
- Author, review, and approve qualification protocols, reports, and SOPs, ensuring accuracy, completeness, and regulatory compliance.
- Collaborate with cross-functional teams including, Engineering, Quality Assurance, and Manufacturing across both facilities to ensure qualification readiness and operational handover.
- Develop and implement change control processes, ensuring modifications to equipment are properly assessed, requalified where required, and documented across both sites.
- Identify and implement process improvement and optimisation opportunities across equipment qualification activities on campus.
- Collaborate with external vendors and contractors to ensure proper installation, qualification, and requalification of equipment, including review and approval of vendor documentation.
- Provide training, mentorship, and performance management to the team of Equipment Qualification Senior Specialists to support professional growth and development.
- Support internal and external audits and inspections related to equipment qualification activities across the campus; address findings and implement corrective actions as required.
Qualifications & Experience
- Bachelor's or Master's degree in Engineering, Life Sciences, or a related discipline.
- Extensive experience in Equipment Qualification (IQ/OQ/PQ) and requalification within a GMP-regulated biologics or pharmaceutical environment.
- Demonstrated experience leading and managing CQV teams in a project or operational setting.
- Experience developing and implementing equipment qualification strategies and managing qualification projects from concept through to lifecycle closure.
- Strong understanding of regulatory requirements (FDA, EMA, ICH) and industry standards (ISPE Baseline Guides).
- 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
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-Hybrid
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.
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