Autoclave CQV SME — Sterilisation & Temperature Mapping

Bristol-Myers Squibb Co; Cruiserath; Hybrid; EUR 110,000 - 150,000; Full time

Benefits offered by this job

Annual bonus

Pension contribution

Life assurance

On-site gym

Job summary

Bristol-Myers Squibb Cruiserath is seeking a senior Engineering CQV Subject Matter Expert specializing in autoclaves and temperature mapping. The role requires independent leadership of complex qualification projects and acts as the primary SME during regulatory inspections across MPCC and SDPF sites.

You will develop qualification strategies, perform cycle development, and mentor CQV staff while ensuring compliance with GMP expectations. Hybrid work model options apply at the Cruiserath campus.

Qualifications

• Bachelor's or Master's degree in Engineering or related field; PhD advantageous.
• Minimum 10 years' progressive CQV experience in pharmaceutical/biologics.
• Deep expertise in autoclave qualification and temperature mapping in GMP environments.
• Experience acting as SME during regulatory inspections and audits.

Responsibilities

• Act as campus CQV SME and technical authority for autoclave qualification and temperature mapping.
• Lead autoclave commissioning, qualification activities, and cycle development.
• Perform temperature mapping studies, data assessment, and establish acceptance criteria.
• Review protocols, reports, deviations, CAPAs, and technical documentation.
• Support regulatory inspections and provide authoritative technical responses.

Skills

CQV leadership

Autoclave qualification

Temperature mapping

Regulatory inspections

Education

Engineering degree

PhD advantageous

Tools

GMP systems

Job description

Bristol-Myers Squibb Cruiserath is seeking a senior Engineering CQV Subject Matter Expert specializing in autoclaves and temperature mapping. The role requires independent leadership of complex qualification projects and acts as the primary SME during regulatory inspections across MPCC and SDPF sites.

You will develop qualification strategies, perform cycle development, and mentor CQV staff while ensuring compliance with GMP expectations. Hybrid work model options apply at the Cruiserath campus.