Autoclave CQV SME: Sterilization Expert

Bristol Myers Squibb; Ireland; On-site; EUR 120,000 - 170,000; 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 specialising in autoclaves and equipment temperature mapping. This senior role offers autonomy, leadership, and the chance to drive qualification programs across MPCC and SDPF sites under a campus approach.

You will act as the technical authority for autoclave qualification, participate in regulatory inspections, mentor CQV staff, and collaborate with QA, Manufacturing, and Engineering to deliver compliant qualification projects.

Qualifications

• Minimum 10 years in pharmaceutical CQV with autoclave qualification.
• Proven lead on complex autoclave qualification and cycle development.
• Experience as SME during regulatory inspections and audits.

Responsibilities

• Act as campus CQV SME and autoclave qualification authority.
• Lead autoclave commissioning and qualification activities.
• Oversee temperature mapping studies and data assessment.
• Develop qualification plans, protocols, and reports.
• Support regulatory inspections and audits with technical responses.
• Mentor CQV staff and drive best practices.

Skills

CQV expertise

Autoclave qualification

Temperature mapping

Regulatory inspections

Mentoring CQV staff

GMP knowledge

Risk-based validation

Education

Engineering or Life Sciences degree

Job description

BMS Cruiserath Biologics is seeking a permanent Engineering CQV SME specialising in autoclaves and equipment temperature mapping. This senior role offers autonomy, leadership, and the chance to drive qualification programs across MPCC and SDPF sites under a campus approach.

You will act as the technical authority for autoclave qualification, participate in regulatory inspections, mentor CQV staff, and collaborate with QA, Manufacturing, and Engineering to deliver compliant qualification projects.