Manager, Engineering Computer Systems Validation (CSV)

Job description

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 SummaryBMS Cruiserath Biologics is seeking to recruit one permanent Manager, Engineering Computer Systems Validation (CSV). The role is part of the Engineering Commissioning, Qualification and Validation (CQV) team and operates under a campus approach, with responsibility for the CSV programme 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, Engineering CSV will lead the CSV programme and a team of CSV Senior Specialists, developing and implementing CSV strategies and driving continuous improvement to enhance the efficiency, compliance, and effectiveness of CSV and CQV operations across both facilities. CQV experience, including equipment commissioning and qualification (IQ, OQ, PQ), is an advantage given the close link between validated equipment and the computerised systems that control it. Role Overview The Manager, Engineering CSV is responsible for leading the CSV programme across the MPCC and SDPF facilities. The role encompasses CSV strategy and master planning in accordance with GAMP 5, 21 CFR Part 11, and Annex 11, oversight of deliverable authoring and review, data integrity assurance across all validated computerised systems on campus, management of the CSV team, and close collaboration with IT, Engineering, Quality Assurance, Regulatory Affairs, MS&T, and Manufacturing. The role works alongside the equipment qualification team so that automated equipment and control systems are commissioned, qualified, and validated in an integrated and efficient manner. Key Responsibilities • Lead the CSV programme across MPCC and SDPF, reporting progress and escalations to the Sr. Manager, Engineering CQV. • Develop and maintain the CSV strategy, validation master plan, and risk-based approaches in line with GAMP 5, 21 CFR Part 11, and EU Annex 11. • Plan, coordinate, and oversee CSV activities across the full system lifecycle, from concept and supplier assessment through periodic review and retirement, ensuring timely completion and adherence to budget. • Oversee the authoring, review, and approval of CSV deliverables, including validation plans, user and functional requirements, risk assessments, configuration and design specifications, test protocols (IQ/OQ/PQ), traceability matrices, SOPs, and summary reports. • Ensure data integrity compliance (ALCOA+) across all validated computerised systems, including process control, laboratory, manufacturing execution, and enterprise systems. • Provide oversight of validated state maintenance, including change control, periodic review, backup and recovery, access management, audit trail review, and system decommissioning. • Conduct and review risk assessments and develop and implement mitigation strategies. • Provide expert technical input to changes, deviations, CAPAs, investigations, and periodic reviews that may affect the validated state of computerised systems. • Work with the equipment qualification team to coordinate commissioning, qualification, and validation of automated equipment and systems, ensuring qualification readiness and operational handover. • Collaborate with IT, Engineering, Quality Assurance, Regulatory Affairs, MS&T, Manufacturing, and vendors to align validation activities with project and operational objectives across both facilities. • Review and approve vendor documentation, supplier assessments, and factory and site testing outputs for computerised systems. • Act as the primary CSV representative during regulatory inspections, health authority audits, and internal audits, addressing findings and implementing corrective actions as required. • Provide training, mentorship, and performance management to CSV team members to support professional growth and development. • Identify, champion, and implement innovation, standardisation, and continuous improvement opportunities across CSV and CQV, including risk-based and computer software assurance (CSA) approaches where appropriate. Technical Scope• CSV lifecycle management for GxP computerised systems, including planning, specification, risk assessment, testing, release, and retirement. • Process control and automation systems such as DeltaV, manufacturing execution systems (MES), and enterprise systems such as SAP, together with laboratory and building management systems. • Supplier assessment and use of vendor documentation, including leveraging supplier testing in a risk-based manner. • Data integrity (ALCOA+), electronic records and signatures, audit trail review, user access management, and backup and recovery. • Lifecycle maintenance of validated state, including change impact assessment, periodic review, and risk-based revalidation. • Integration of CSV with equipment commissioning and qualification for automated equipment and control systems. Qualifications and Experience• Bachelor's or Master's degree in Engineering, Computer Science, Life Sciences, or a related discipline. • Extensive experience in Computer Systems Validation (GAMP 5, 21 CFR Part 11, Annex 11) within a GMP-regulated biologics or pharmaceutical environment. • Demonstrated experience leading and managing CSV or validation teams in a project or operational setting. • Experience developing and implementing CSV strategies and managing validation projects from concept through to lifecycle closure. • Strong understanding of regulatory requirements (FDA, EMA, ICH), data integrity expectations (ALCOA+), and industry standards (GAMP 5, ISPE Baseline Guides). • Experience with risk-based validation approaches and quality risk management, including change control, deviations, investigations, and CAPAs. • Proven experience supporting health authority inspections and internal audits, including responding to observations and implementing CAPAs. • Excellent technical writing, review, communication, and presentation skills. • 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. • Familiarity with systems such as DeltaV, MES, SAP, or laboratory and building management systems is highly desirable. • Experience in commissioning, qualification, and validation (CQV) of equipment (IQ/OQ/PQ), including requalification, is an advantage. • Previous experience in biologics manufacturing, aseptic processing, or sterile drug product operations is an advantage. Regulatory and Industry Knowledge• Applicable GMP and regulatory expectations from the FDA, EMA, and other relevant health authorities. • GAMP 5, 21 CFR Part 11, and EU GMP Annex 11, together with current industry guidance on computerised systems and risk-based validation. • Good Documentation Practice and data integrity principles applicable to electronic and paper records. 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 perfect