Senior CQV Engineer: Autoclaves & Temperature Mapping SME

Bristol-Myers Squibb Co; Cruiserath; On-site; 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 Cruiserath Biologics is seeking a permanent Engineering CQV Subject Matter Expert (SME) specialising in autoclaves and equipment temperature mapping. This senior role delivers autonomous, high‑impact qualification projects across MPCC and SDPF sites.

Reporting to the Associate Director, Engineering CQV, you will lead autoclave qualification, cycle development, temperature mapping studies, risk‑based qualification, and CAPA resolution in a GMP environment.

Qualifications

• 10+ years in pharmaceutical/biologics CQV
• Specialist in autoclave qualification and temperature mapping
• Experience leading complex CQV studies in GMP environments

Responsibilities

• Act as campus CQV SME and autoclave technical authority
• Lead autoclave commissioning, qualification, and cycle development
• Oversee temperature distribution and heat penetration studies
• Review protocols, reports, and risk assessments
• Support regulatory inspections and audits
• Mentor CQV staff and drive best practices

Skills

Autoclave qualification

Temperature mapping

CQV leadership

Regulatory inspections

Education

Bachelor's or Master's in Engineering/Science

PhD advantageous

Tools

GMP knowledge

Job description

Bristol Myers Squibb Cruiserath Biologics is seeking a permanent Engineering CQV Subject Matter Expert (SME) specialising in autoclaves and equipment temperature mapping. This senior role delivers autonomous, high‑impact qualification projects across MPCC and SDPF sites.

Reporting to the Associate Director, Engineering CQV, you will lead autoclave qualification, cycle development, temperature mapping studies, risk‑based qualification, and CAPA resolution in a GMP environment.