Engineering CQV SME - Sterilisation / Autoclaves

Bristol Myers Squibb; Fingal; Hybrid; EUR 90,000 - 130,000; Full time

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 is seeking a permanent Engineering CQV Subject Matter Expert specializing in autoclaves and temperature mapping. This senior role leads complex qualification activities within a GMP environment and reports to the Associate Director, Engineering CQV.

Based at BMS Cruiserath, you will drive lifecycle qualification strategies, mentor CQV staff, and collaborate with QA, Manufacturing, Engineering, and vendors to ensure compliant handover and sustained equipment integrity.

Qualifications

• Bachelor’s or Master’s degree in a relevant field; PhD advantageous.
• Minimum 10 years in pharmaceutical CQV with autoclave expertise.
• Proven lead in autoclave qualification, cycle development, and thermal mapping.

Responsibilities

• Provide technical leadership for autoclave qualification and temperature mapping across MPCC/SDPF.
• Lead autoclave commissioning, qualification activities from project initiation to lifecycle closure.
• Oversee study design for temperature distribution and heat penetration; assess data and conclusions.
• Lead or support cycle development, validation, and lifecycle requalification.
• Develop risk-based qualification strategies and maintain quality documentation.
• Review qualification plans, protocols, reports, and deviations; support CAPAs.
• Act as SME during regulatory inspections and audits; provide clear technical responses.

Skills

Leadership

CQV expertise

Autoclave qualification

Temperature mapping

Regulatory knowledge

Mentoring

Technical writing

Education

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

PhD advantageous

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 one permanent Engineering Commissioning, Qualification and Validation (CQV) Subject Matter Expert (SME) specialising in autoclaves and equipment temperature mapping. This senior role is intended for a highly accomplished validation professional with substantial experience in CQV activities within a regulated biopharmaceutical or pharmaceutical environment. The position is part of the Engineering CQV team and supports CQV activities across the Multi-Product Cell Culture (MPCC) and Sterile Drug Product Facility (SDPF) sites under a campus approach. The role reports directly to the Associate Director, Engineering CQV.

Role Overview

The Engineering CQV SME is responsible for providing technical leadership and oversight for equipment qualification and temperature mapping, with specific SME responsibility for autoclave systems. The role encompasses qualification strategy, temperature distribution and heat penetration studies, cycle development and performance qualification, protocol and report review, troubleshooting, deviation support, change assessment, and lifecycle requalification.

Key Responsibilities

• Act as the campus Engineering CQV SME and technical authority for autoclave qualification and equipment temperature mapping across MPCC and SDPF.
• Independently develop, lead, and execute complex autoclave commissioning and qualification activities from project initiation through lifecycle closure.
• Provide technical oversight for temperature distribution and heat penetration studies, including study design, load configuration, sensor placement, acceptance criteria, data assessment, and final conclusions.
• Lead or support autoclave cycle development, cycle optimisation, validation, performance qualification, and lifecycle management activities.
• Develop, maintain, and continuously improve risk-based qualification and temperature mapping strategies, standards, templates, and best-practice frameworks.
• Author, review, and approve qualification plans, protocols, reports, risk assessments, traceability documentation, SOPs, and supporting technical documents.
• Review and assess temperature mapping results, including cold and hot spot identification, equilibration, lethality or sterilisation performance, deviations, anomalies, and technical issues.
• Provide expert technical input to changes, deviations, CAPAs, investigations, periodic reviews, and requalification assessments that may affect autoclave or equipment qualification status.
• Ensure qualification activities are appropriately planned, executed, documented, and maintained in accordance with the approved CQV strategy, site procedures, and applicable regulatory expectations.
• Act as the primary Autoclave and Temperature Mapping SME during regulatory inspections, health authority audits, and internal audits, providing clear and authoritative technical responses.
• Provide technical leadership, coaching, and mentoring to junior and mid-level CQV staff and support the development of site capability in autoclave qualification and temperature mapping.
• Collaborate with Quality Assurance, Manufacturing, Engineering, MS&T, Microbiology, Operations, and vendors to resolve issues and deliver compliant qualification and handover.
• Review and approve relevant vendor documentation, factory and site testing outputs, calibration information, and technical assessments for autoclaves and temperature mapping systems.
• Identify, champion, and implement innovation, standardisation, and continuous improvement opportunities within Engineering CQV.

Technical Scope

• Autoclave commissioning and qualification, including IQ, OQ, PQ, cycle development, and requalification.
• Porous-load, component, equipment-part, liquid-load, and other applicable autoclave cycle types.
• Temperature distribution and heat penetration mapping for autoclaves and other temperature-controlled equipment, as required.
• Thermocouple and data-logger deployment, calibration, pre- and post-study verification, data acquisition, and data integrity.
• Load pattern development, worst-case selection, biological and chemical indicator strategy, and scientifically justified acceptance criteria.
• Troubleshooting of cycle failures, mapping variability, instrumentation issues, and qualification deviations.
• Lifecycle maintenance of validated state, including change impact assessment, periodic review, and risk-based requalification.

Qualifications and Experience

• Bachelor’s or Master’s degree in Engineering, Science, Microbiology, Life Sciences, or a related discipline. A PhD is advantageous.
• A minimum of 10 years of progressive experience in pharmaceutical or biologics CQV, with deep specialist expertise in autoclave qualification and equipment temperature mapping.
• Demonstrated experience independently leading complex autoclave qualification, cycle development, temperature distribution, heat penetration, and performance qualification studies in a GMP-regulated environment.
• Strong knowledge of moist heat sterilisation principles, thermal mapping methodology, sterilisation science, instrumentation, calibration, data assessment, and validation lifecycle management.
• Proven experience acting as an SME during regulatory inspections and health authority audits, with the ability to provide clear, confident, and accurate technical responses.
• Extensive experience with risk-based validation approaches and quality risk management, including change control, deviations, investigations, CAPAs, and requalification.
• Demonstrated experience mentoring and developing validation professionals.
• Exceptional technical writing, review, communication, and presentation skills.
• Proven ability to operate independently, manage competing priorities, and deliver in a complex, fast-paced, multi-facility campus environment.
• Strong stakeholder management skills with the ability to influence and engage at all levels of the organisation.
• Previous experience in biologics manufacturing, aseptic processing, sterile drug product operations, or a startup facility is highly desirable.

Regulatory and Industry Knowledge

• Applicable GMP and regulatory expectations from the FDA, EMA, and other relevant health authorities.
• EU GMP Annex 1 and applicable expectations for sterilisation and contamination control.
• Current industry guidance and recognised standards relevant to moist heat sterilisation, autoclave qualification, thermal mapping, and risk-based qualification.
• Good Documentation Practice and data integrity principles applicable to electronic and paper qualification records.

Why you should apply

• You will help patients in their fight against serious diseases
• You willbe part ofa company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
• You’ll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical allowance, 27 days of annual leave,life assurance and on-site gym

#LI-Hybrid

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Data Protection

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R1607967 : Engineering CQV SME - Sterilisation / Autoclaves