Sterility & Contamination Investigator – GMP Support

Bristol Myers Squibb; New Brunswick (NJ); On-site; USD 109,000 - 132,000; Full time

Benefits offered by this job

Flexible Time Off

11 paid company holidays

Job summary

Bristol Myers Squibb in New Brunswick, NJ is seeking a Manager, Contamination Events & Sterility Assurance Support to lead complex investigations and support aseptic processing within GMP facilities.

You will collaborate with global QA, Microbiology, and manufacturing teams, review RCA and CAPA documentation, contribute to deviation assessment, and help prepare for regulatory inspections while advancing sterility assurance and contamination control initiatives.

Qualifications

• Bachelor-level science degree required; relevant GMP/pharma experience preferred.
• Minimum 3 years (BS) or 1 year (MS) in microbiology/sterility assurance within GMP-regulated environment.
• Familiarity with regulatory requirements including FDA 21 CFR Parts 210/211, EU GMP Annex 1, and USP microbiology chapters.

Responsibilities

• Support investigations of microbiological events at internal manufacturing sites and CMOs/CDMOs.
• Evaluate RCA and contribute to product, process, and patient impact assessments under senior guidance.
• Maintain and contribute to deviation records and CAPA effectiveness in GMP environment.

Skills

GMP documentation

Data analysis

Environmental monitoring

Sterility assurance

Cross-functional collaboration

Regulatory knowledge

Education

B.S. in Microbiology or related

Tools

TrackWise

Veeva Vault

Job description

Bristol Myers Squibb in New Brunswick, NJ is seeking a Manager, Contamination Events & Sterility Assurance Support to lead complex investigations and support aseptic processing within GMP facilities.

You will collaborate with global QA, Microbiology, and manufacturing teams, review RCA and CAPA documentation, contribute to deviation assessment, and help prepare for regulatory inspections while advancing sterility assurance and contamination control initiatives.