Global Lead, Aseptic Facility & Utilities Design

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

Benefits offered by this job

Wellbeing support

Retirement plan

Medical, dental, vision insurance

Job summary

Bristol Myers Squibb in New Brunswick, NJ, seeks an Associate Director for Aseptic Facility and Utility Design. You will lead aseptic facility design, CCS strategy, and regulatory readiness across sites, with emphasis on WFI, PW, clean steam, and critical utilities.

Responsibilities include defining enterprise standards for aseptic design, validating changes, and ensuring contamination control throughout the lifecycle of facilities and utilities. Travel up to 25% may be required.

Qualifications

• B.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry or related field required.
• 10+ years in sterility assurance, aseptic manufacturing, microbiology or pharmaceutical quality.
• 4+ years in leadership or enterprise-level role.
• Experience 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 resolution of systemic issues.
• Develop and maintain investigation materials for aseptic and microbial control issues during regulatory inspections.

Skills

Aseptic processing

Environmental monitoring

Microbial risk assessment

Quality by Design (QbD)

Regulatory inspections (FDA/EMA)

Education

B.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry

Tools

Sterilization technologies (EtO, gamma, steam)

CCS design standards experience

Job description

Bristol Myers Squibb in New Brunswick, NJ, seeks an Associate Director for Aseptic Facility and Utility Design. You will lead aseptic facility design, CCS strategy, and regulatory readiness across sites, with emphasis on WFI, PW, clean steam, and critical utilities.

Responsibilities include defining enterprise standards for aseptic design, validating changes, and ensuring contamination control throughout the lifecycle of facilities and utilities. Travel up to 25% may be required.