Senior Autoclave CQV SME – Thermal Mapping & Sterilization

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

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.