Manager, Engineering Computer Systems Validation (CSV)

Bristol-Myers Squibb; Cruiserath; On-site; EUR 120,000 - 150,000; Full time

Job summary

Bristol Myers Squibb Cruiserath is recruiting a permanent Manager, Engineering CSV to lead the CSV programme across MPCC and SDPF facilities. You will develop strategies, manage a CSV team, and ensure validated systems meet regulatory and quality standards.

The role reports to the Sr. Manager, Engineering CQV, collaborating with IT, Engineering, QA, Regulatory, and Manufacturing to optimize validation activities and drive continuous improvement.

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.

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 Summary

BMS 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 documentat