Manager, Senior Engineer Engineering Commissioning, Qualification & Validation

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

At Bristol Myers Squibb, our employees often ask, "Who are you working for?"-a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Position Summary

BMS Cruiserath Biologics is seeking to recruit a Manager, Engineering Commissioning, Qualification and Validation (CQV) - Equipment Qualification / Requalifications. This is a 12 month fixed -term contract role.

The role is part of the Engineering CQV team and operates under a campus approach, with responsibility for equipment qualification and requalification activities across both the Multi-Product Cell Culture (MPCC) and Sterile Drug Product Facility (SDPF) sites. The role reports to the Sr. Manager, Engineering CQV. The manager will develop and implement equipment qualification and requalification strategies, and drive continuous improvement initiatives to enhance the efficiency, compliance, and effectiveness of CQV operations across both facilities.

Role Overview

This role is responsible for leading equipment qualification and requalification activities (IQ, OQ, PQ) across the MPCC and SDPF facilities. The manager will develop and implement equipment qualification and requalification strategies, oversee commissioning and start-up activities, manage a team of Equipment Qualification Senior Specialists, and ensure all qualification work is executed in compliance with FDA, EMA, and GMP requirements. The role will interface with Manufacturing, and Engineering teams across both sites to ensure qualification readiness and operational handover.

Key Responsibilities

• Operating under a campus approach across the MPCC and SDPF facilities, and reporting progress and escalations to the Sr. Manager, Engineering CQV.
• Plan, coordinate, and oversee equipment commissioning, qualification (IQ/OQ/PQ), and requalification activities across both sites, ensuring timely completion and adherence to budget.
• Develop and implement equipment qualification and requalification strategies, master plans, and risk-based approaches aligned with current regulatory expectations for both MPCC and SDPF.
• Manage the periodic requalification programme to maintain the qualified state of equipment throughout its lifecycle.
• Ensure compliance with applicable regulatory requirements (FDA, EMA, ICH, GMP) and internal quality standards and procedures.
• Conduct and review risk assessments; develop and implement mitigation strategies.
• Author, review, and approve qualification protocols, reports, and SOPs, ensuring accuracy, completeness, and regulatory compliance.
• Collaborate with cross-functional teams including, Engineering, Quality Assurance, and Manufacturing across both facilities to ensure qualification readiness and operational handover.
• Develop and implement change control processes, ensuring modifications to equipment is properly assessed, requalified where required, and documented across both sites.
• Identify and implement process improvement and optimisation opportunities across equipment qualification activities on campus.
• Collaborate with external vendors and contractors to ensure proper installation, qualification, and requalification of equipment, including review and approval of vendor documentation.
• Provide training, mentorship, and performance management to the team of Equipment Qualification Senior Specialists to support professional growth and development.
• Support internal and external audits and inspections related to equipment qualification activities across the campus; address findings and implement corrective actions as required.

Qualifications & Experience

• 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 a GMP-regulated biologics or pharmaceutical environment.
• Demonstrated experience leading and managing CQV teams in a project or operational setting.
• Experience developing and implementing equipment qualification strategies and managing qualification projects from concept through to lifecycle closure.
• Strong understanding of regulatory requirements (FDA, EMA, ICH) and industry standards (ISPE Baseline Guides).
• Experience conducting risk assessments and developing mitigation strategies in a GMP environment.
• Proficiency in preparing and reviewing qualification protocols, reports, and SOPs; excellent technical writing skills are essential.
• Proven ability to collaborate with cross-functional teams and manage multiple stakeholders across a multi-facility campus environment.
• Demonstrated track record of driv