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
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