CQV Engineering Manager — Equipment Qualification

Bristol-Myers Squibb Co; Cruiserath; Vor Ort; EUR 90.000 - 120.000; Vollzeit

Benefits dieser Stelle

Annual bonus

Pension contribution

Family medical allowance

27 days annual leave

Life assurance

On-site gym

Zusammenfassung

BMS Cruiserath Biologics is seeking a Manager, Engineering CQV – Equipment Qualification / Requalifications. This is a 12 month fixed-term contract. The manager will lead CQV activities (IQ / OQ / PQ) across MPCC and SDPF, develop strategies, and mentor a team, reporting to the Sr.

Manager, Engineering CQV. The role ensures FDA/EMA/ICH/GMP compliance, conducts risk assessments, reviews protocols and reports, and partners with Manufacturing and Quality Assurance to achieve qualification readiness

Qualifikationen

• Experience leading CQV activities in GMP biologics or pharmaceutical environments.
• Ability to develop and implement equipment qualification strategies.
• Strong regulatory knowledge and documentation skills.
• Experience managing CQV projects across multiple sites.

Aufgaben

• Lead CQV activities (IQ/OQ/PQ) across MPCC and SDPF facilities.
• Develop CQV master plans and risk-based qualification strategies.
• Manage a team of Equipment Qualification Senior Specialists.
• Ensure compliance with FDA/EMA/ICH and GMP requirements.
• Collaborate with Manufacturing, Engineering and QA across both sites.
• Review and approve qualification protocols, reports, and SOPs.

Kenntnisse

CQV experience (IQ/OQ/PQ)

Leadership

Regulatory knowledge (FDA/EMA/ICH)

Technical writing

Cross-functional collaboration

GMP compliance

Risk-based approach

Ausbildung

Bachelor's or Master's in Engineering or Life Sciences

Jobbeschreibung

BMS Cruiserath Biologics is seeking a Manager, Engineering CQV – Equipment Qualification / Requalifications. This is a 12 month fixed-term contract. The manager will lead CQV activities (IQ / OQ / PQ) across MPCC and SDPF, develop strategies, and mentor a team, reporting to the Sr.

Manager, Engineering CQV. The role ensures FDA/EMA/ICH/GMP compliance, conducts risk assessments, reviews protocols and reports, and partners with Manufacturing and Quality Assurance to achieve qualification readiness