CSV Engineering Manager: Lead Validation for Biologics Ops

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

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.