Sterility Assurance & Contamination Events Specialist

Bristol Myers Squibb; Dublin; Hybrid; EUR 95,000 - 126,000; Full time

Benefits offered by this job

Wellbeing support

Retirement plan

Insurance (medical, dental, vision, 1)

Job summary

Bristol Myers Squibb in Ireland seeks a Manager for Contamination Events & Sterility Assurance Support to lead microbiology investigations and support aseptic manufacturing at internal and external sites. You will collaborate with Quality, MS&T, Manufacturing, and external partners to ensure robust CAPA processes.

The role emphasizes scientific rigor, regulatory knowledge (FDA/EU), and data-driven risk assessments, with travel up to 25% and a focus on patient safety and quality.

Qualifications

• BS in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry or related field.
• 3+ years microbiology, sterility or aseptic manufacturing experience (BS) or 1 year (MS).
• Knowledge of USP <71>, <1116>, FDA and EU GMP requirements.
• Experience contributing to GMP impact assessments and CAPA documentation.

Responsibilities

• Support investigation impact assessments at internal sites (environmental monitoring, bioburden, sterility failures).
• Evaluate RCA and contribute to product/process/patient impact analyses.
• Assist in documentation, deviation records, and CAPA reviews.
• Support ExM partner QC reviews and risk assessments at CMOs/CDMOs.
• Contribute to CCS development and monitoring of aseptic processing operations.
• Assist in preparation for inspections and regulatory audits.

Skills

Scientific curiosity

Written communication

Organizational skills

Growth mindset

Education

BS in Microbiology / Pharmaceutical Sciences / Biology / Biochemistry

Tools

TrackWise / Veeva Vault

Job description

Bristol Myers Squibb in Ireland seeks a Manager for Contamination Events & Sterility Assurance Support to lead microbiology investigations and support aseptic manufacturing at internal and external sites. You will collaborate with Quality, MS&T, Manufacturing, and external partners to ensure robust CAPA processes.

The role emphasizes scientific rigor, regulatory knowledge (FDA/EU), and data-driven risk assessments, with travel up to 25% and a focus on patient safety and quality.