Engineering CSV Manager – GMP Systems & Compliance

Bristol-Myers Squibb Co

Cruiserath

On-site

EUR 120,000 - 180,000

Full time

8 days ago

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Benefits offered by this job

Annual bonus

Pension contribution

Family medical allowance

27 days annual leave

Life assurance

On-site gym

Job summary

Bristol-Myers Squibb Cruiserath Biologics is hiring a Manager, Engineering CSV to lead the CSV programme for MPCC and SDPF facilities. You will drive validation strategy, master planning, and risk-based validation in collaboration with IT, QA, Regulatory Affairs, and Manufacturing.

The role requires strong leadership, regulatory knowledge, and expert technical writing to support inspections. You will manage a CSV team, oversee IQ/OQ/PQ deliverables, and ensure data integrity and lifecycle

Qualifications

Bachelor's or Master's degree in Engineering, Computer Science, Life Sciences, or related discipline.
Extensive experience in Computer Systems Validation (GAMP 5, 21 CFR Part 11, EU Annex 11) within GMP-biologics/pharma.
Experience leading CSV or validation teams in project or operation settings.
Familiarity with regulatory requirements and data integrity expectations (ALCOA+).

Responsibilities

Lead the CSV programme across MPCC and SDPF facilities and report progress.
Develop CSV strategy and risk-based validation plans in line with GAMP 5 and Part 11.
Oversee delivery of CSV documents (validation plans, requirements, protocols, SARs, traceability).
Ensure data integrity and change control across validated systems.
Collaborate with IT, Engineering, QA, Regulatory, and Manufacturing to align activities.