Senior CQV Engineer: Autoclave & Temperature Mapping

Bristol Myers Squibb UK & Ireland; Ireland; On-site; EUR 110,000 - 150,000; 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

BMS Cruiserath Biologics is seeking a permanent Engineering CQV SME specializing in autoclaves and temperature mapping. You will lead qualification strategies, develop validation cycles, review reports, and support regulatory inspections across MPCC and SDPF sites.

This senior role requires a track record in CQV within GMP environments, mentoring junior staff, and delivering lifecycle qualification with risk-based approaches.

Qualifications

• Bachelor’s or Master’s degree in Engineering, Science, Microbiology, Life Sciences, or related; PhD advantageous.
• Minimum of 10 years in pharmaceutical/biologics CQV with autoclave expertise.
• Experience leading autoclave qualification, cycle development, temperature distribution, heat penetration, PQ studies in GMP environments.
• Strong knowledge of moist heat sterilisation, thermal mapping, validation lifecycle management.
• Experience as SME during regulatory inspections and audits; risk-based validation approaches.
• Mentoring validation professionals and clear technical communication.

Responsibilities

• Act as campus CQV SME and technical authority for autoclave qualification across MPCC/SDPF.
• Lead and execute complex autoclave commissioning and qualification activities end-to-end.
• Oversee temperature mapping studies, sensor placement, acceptance criteria, and data assessment.
• Lead autoclave cycle development, validation, and lifecycle management activities.
• Develop and improve qualification strategies, templates, and best practices.
• Author and approve qualification plans, protocols, reports, risk assessments, SOPs.
• Review mapping results; address deviations, anomalies, and issues.
• Provide input on changes, CAPAs, investigations, and requalification decisions.
• Ensure CQV activities comply with CQV strategy and regulatory expectations.
• Support regulatory inspections with expert technical responses.
• Mentor junior/mid-level CQV staff and build site capability.

Skills

CQV leadership

Autoclave qualification

Temperature mapping

Regulatory inspections support

Technical writing

Education

Bachelor/Master in Engineering or Life Sciences

Job description

BMS Cruiserath Biologics is seeking a permanent Engineering CQV SME specializing in autoclaves and temperature mapping. You will lead qualification strategies, develop validation cycles, review reports, and support regulatory inspections across MPCC and SDPF sites.

This senior role requires a track record in CQV within GMP environments, mentoring junior staff, and delivering lifecycle qualification with risk-based approaches.