Global Lead, Aseptic Facility & Utilities Design

Bristol Myers Squibb EU Policy; New Brunswick (NJ); On-site; USD 162,000 - 196,000; Full time

Benefits offered by this job

Flexible Time Off

11 paid company holidays

Healthcare benefits

Job summary

Bristol Myers Squibb in New Brunswick, NJ seeks an Associate Director, Aseptic Facility and Utility Design to lead sterile facility design and CCS programs across global sites.

You will partner with Engineering, Validation, Regulatory, and Quality to ensure design compliance with EU GMP Annex 1, FDA guidance, ISO standards, and lifecycle management, with up to 25% travel. The role requires deep expertise in aseptic processing, single-use technology, IQ/OQ/PQ, and CAPEX oversight.

Qualifications

• 10+ years of experience in sterility assurance or aseptic manufacturing.
• Deep expertise in aseptic processing, environmental monitoring, contamination control, and microbial risk assessment.
• Experience authoring/reg defending technical positions during regulatory inspections (FDA PAI/GMP, EMA).

Responsibilities

• Review and approve global risk assessments and quality impact assessments for contamination events.
• Lead and author high-complexity BTAs to support regulatory submissions and cross-site alignment.
• Develop and maintain investigation materials for systemic aseptic issues and regulatory inspections.

Skills

Aseptic processing

Environmental monitoring

Contamination control

Microbial risk assessment

Regulatory inspections

Quality by Design

Education

B.S. in Microbiology/Pharmaceutical Sciences/Biology/Biochemistry or related

Job description

Bristol Myers Squibb in New Brunswick, NJ seeks an Associate Director, Aseptic Facility and Utility Design to lead sterile facility design and CCS programs across global sites.

You will partner with Engineering, Validation, Regulatory, and Quality to ensure design compliance with EU GMP Annex 1, FDA guidance, ISO standards, and lifecycle management, with up to 25% travel. The role requires deep expertise in aseptic processing, single-use technology, IQ/OQ/PQ, and CAPEX oversight.