Associate Director, Global Aseptic Design & Utilities

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

Benefits offered by this job

Flexible Time Off

11 paid holidays

Insurance (medical, dental, vision)

Retirement and stock options

Job summary

Bristol Myers Squibb, in New Brunswick, NJ, seeks an Associate Director to lead aseptic facility and utility design. You will drive design standards, risk assessments, and regulatory interactions across global sites to ensure robust contamination control and compliance.

You will partner with Engineering and Validation to ensure IQ/OQ/PQ coverage and will oversee sterile and non-sterile facility changes throughout the enterprise lifecycle.

Qualifications

• 10+ years in sterility assurance or aseptic manufacturing with leadership experience.
• Deep expertise in aseptic processing, environmental monitoring, and microbial risk assessment.

Responsibilities

• Review and approve global risk assessments and QIAs for contamination events around Facilities & Utilities.
• Lead and author high-complexity BTAs to support regulatory submissions and cross-site alignment.
• Develop investigation and inspection-readiness materials for aseptic issues during regulatory inspections.

Skills

Aseptic processing

Contamination control

Environmental monitoring

Regulatory inspections

CCS development

Education

Bachelor's degree in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, or related

Tools

URS review

DQ protocols

IQ/OQ/PQ

Job description

Bristol Myers Squibb, in New Brunswick, NJ, seeks an Associate Director to lead aseptic facility and utility design. You will drive design standards, risk assessments, and regulatory interactions across global sites to ensure robust contamination control and compliance.

You will partner with Engineering and Validation to ensure IQ/OQ/PQ coverage and will oversee sterile and non-sterile facility changes throughout the enterprise lifecycle.