Associate Director, Aseptic Facility and Utility Design

Bristol Myers Squibb • New Brunswick, NJ

18d • $161,950 - $215,867

About The Position

The Associate Director, Aseptic Facility and Utility Design serves as a global Quality subject matter expert for aseptic facility and utility design, contamination control, sterilization standards, and single-use technology. The role provides enterprise-level oversight and governance across facility and equipment lifecycles, capital projects, facility modifications, technology transfers, and external manufacturing partners. It ensures designs and qualification programs meet BMS standards and applicable regulatory expectations, including EU GMP Annex 1, FDA guidance, and relevant ISO standards.

The position leads complex risk assessments, quality impact assessments, and Business Technical Assessments related to contamination events and microbial control failures. It also develops inspection-readiness materials and serves as a technical expert during regulatory inspections. The role partners closely with Quality, Engineering, Validation, Operations, MS&T, Regulatory, and Supply Chain, and requires travel of up to 25%.

Requirements

• Bachelor of Science in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, or a related scientific discipline.
• 10 or more years of progressive experience in sterility assurance, aseptic manufacturing, microbiology, or pharmaceutical quality.
• At least 4 years of experience in a leadership or enterprise-level role.
• Deep technical expertise in aseptic processing, environmental monitoring, contamination control, and microbial risk assessment in a regulated pharmaceutical or biologics manufacturing environment.
• Demonstrated experience authoring and defending technical positions during regulatory inspections, including FDA PAI/GMP, EMA, and PMDA inspections.
• Track record of designing or overhauling APS/media fill programs or contamination control strategy frameworks at network or enterprise scale.
• Hands-on experience with sterilization validation and single-use system qualification.
• Expert-level knowledge of aseptic processing regulations and guidance, including FDA Aseptic Processing Guidance, EU GMP Annex 1, USP <1116>, ISO 13408 series, and PDA Technical Reports TR22, TR13, TR70, and TR90.
• Strong command of contamination control strategy development as required under EU GMP Annex 1.
• Proficiency in risk assessment methodologies, including FMEA, HACCP, fault tree analysis, and risk ranking and filtering.
• Familiarity with facility design standards, cleanroom classification, and airflow visualization techniques.
• Experience with EtO, gamma, steam (moist heat), dry heat, and VHP/HPV sterilization technologies.
• Strong cross-functional partnership skills across Quality, Operations, MS&T, Regulatory, and Supply Chain.
• Willingness to travel up to 25%.

Nice To Haves

• Master of Science in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, or a related scientific discipline.

Responsibilities

• Review and approve global risk assessments and quality impact assessments related to contamination events and microbial control failures involving facilities and utilities.
• Lead and author complex Business Technical Assessments for regulatory submissions, systemic issue resolution, and cross-site technical alignment.
• Develop and maintain investigation and inspection-readiness materials for systemic aseptic and microbial control issues, and serve as a Facilities & Utilities subject matter expert during regulatory inspections.
• Review and approve design packages, User Requirement Specifications, design qualification protocols, and change controls for cleanrooms, barrier systems, and critical utilities.
• Define and maintain enterprise Quality standards for aseptic facility and utility design, including cleanroom classification, airflow and pressure differentials, surface finishes, and drainability.
• Provide design-stage oversight of facility, utility, and equipment changes to identify, assess, and control microbial and particulate contamination risks.
• Serve as technical authority for aseptic design principles during capital projects, facility modifications, and technology transfers, integrating contamination control strategy requirements into design specifications.
• Provide Quality oversight for WFI, purified water, clean steam, clean compressed gases, and HVAC/clean air systems, including design, qualification, and ongoing microbial and chemical control.
• Partner with Engineering and Validation to ensure IQ/OQ/PQ programs demonstrate microbiological and contamination-control performance against defined acceptance criteria.
• Promote Quality by Design and risk-based thinking throughout facility and equipment lifecycle management.
• Oversee facility and utility design standards at external manufacturing partners, review design packages, contamination control strategy documentation, and utility qualification strategies, and support site qualification and ongoing oversight.
• Assess external manufacturing facility and utility designs for gaps against BMS standards and regulatory expectations, and drive remediation through the external manufacturing quality governance framework.
• Develop and govern enterprise design standards for sterilization technologies, single-use technology, and consumable qualification.
• Define sterilization validation requirements and risk-based bioburden control strategies for components, containers, and sterile fluid pathways.
• Keep sterilization design standards current with regulatory guidance and industry best practices.

Benefits

• Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and insurance offerings.
• Medical, dental, vision, life, and disability insurance offerings.
• Flexible Time Off for eligible U.S.-based exempt employees, subject to manager approval.
• 11 paid company holidays each year.
• For eligible employees, additional time-off benefits may include paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves for medical, personal, parental, caregiver, bereavement, or military needs.
• Eligible employees may receive an annual Global Shutdown between Christmas Day and New Year's Day.
• Potential eligibility for discretionary incentive cash and stock opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior