CQV Engineering Manager - Equipment Qualification

Bristol-Myers Squibb; Cruiserath; On-site; EUR 110,000 - 160,000; Full time

Job summary

Bristol Myers Squibb is seeking a Manager, Engineering Commissioning, Qualification and Validation (CQV) - Equipment Qualification / Requalifications, at the Cruiserath Biologics campus in Ireland. This 12-month fixed-term contract leads a CQV team to ensure IQ/OQ/PQ across MPCC and SDPF facilities.

You will develop qualification strategies, oversee commissioning, and ensure compliance with FDA, EMA and GMP, partnering with Manufacturing and Engineering to deliver qualified equipment and smooth

Qualifications

• Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related discipline.
• Extensive experience in Equipment Qualification (IQ/OQ/PQ) and requalification within GMP-regulated environments.
• Proven experience leading CQV teams and managing qualification projects from concept to lifecycle closure.

Responsibilities

• Lead IQ/OQ/PQ qualification and requalification across MPCC and SDPF campuses.
• Develop strategies, master plans and risk-based approaches aligned with regulatory expectations.
• Oversee commissioning activities and ensure regulatory compliance (FDA, EMA, ICH, GMP).
• Mentor Equipment Qualification Senior Specialists and drive continuous improvement.

Skills

CQV leadership

GMP compliance

Regulatory knowledge (FDA/EMA/ICH)

Cross-functional collaboration

Technical writing

Education

Bachelor’s or Master’s degree in Engineering or Life Sciences

Job description

Bristol Myers Squibb is seeking a Manager, Engineering Commissioning, Qualification and Validation (CQV) - Equipment Qualification / Requalifications, at the Cruiserath Biologics campus in Ireland. This 12-month fixed-term contract leads a CQV team to ensure IQ/OQ/PQ across MPCC and SDPF facilities.

You will develop qualification strategies, oversee commissioning, and ensure compliance with FDA, EMA and GMP, partnering with Manufacturing and Engineering to deliver qualified equipment and smooth