Senior CQV Specialist: Validation & Commissioning

Bristol-Myers Squibb; Cruiserath; On-site; EUR 70,000 - 100,000; Full time

Benefits offered by this job

Annual bonus

Pension contribution

Family medical allowance

27 days of annual leave

Life assurance

On-site gym

Job summary

Bristol Myers Squibb is seeking a permanent Senior Specialist, Engineering CQV to own qualification of process and utility equipment and validation of computerised systems from commissioning through routine operation. You will drive risk-based strategies and ensure inspection-ready documentation across the MPCC and SDPF sites.

The role requires strong CQV experience, knowledge of FDA/EMA/ICH standards, and the ability to lead cross-functional teams in a regulated biopharma environment.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Chemistry or a related field.
• Experience in equipment qualification (IQ/OQ/PQ) and/or computer systems validation (GAMP 5, 21 CFR Part 11, Annex 11).
• Strong knowledge of regulatory requirements (FDA, EMA, ICH) and industry standards.

Responsibilities

• Support commissioning, qualification and validation activities for MPCC and SDPF facilities.
• Develop CQV plans and risk-based strategies for new and existing equipment and systems.
• Author, execute and report IQ, OQ and PQ protocols with functional testing and start-up support.
• Maintain audit-ready validation documentation and support regulatory inspections.
• Collaborate with QA, Manufacturing, Engineering and Regulatory Affairs.

Skills

CQV processes

Regulatory compliance

Risk-based validation

Analytical writing

Communication skills

Education

Bachelor's degree in Engineering, Life Sciences, Chemistry or a related field

Tools

Validation software tools

Job description

Bristol Myers Squibb is seeking a permanent Senior Specialist, Engineering CQV to own qualification of process and utility equipment and validation of computerised systems from commissioning through routine operation. You will drive risk-based strategies and ensure inspection-ready documentation across the MPCC and SDPF sites.

The role requires strong CQV experience, knowledge of FDA/EMA/ICH standards, and the ability to lead cross-functional teams in a regulated biopharma environment.