Associate Director, Aseptic Facility and Utility Design

Bristol Myers Squibb • Devens, MA

19d • $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 at Bristol Myers Squibb. The role provides technical and quality oversight across facility design, capital projects, facility modifications, technology transfers, equipment and utility lifecycle management, and external manufacturing partner oversight. It ensures microbial and particulate contamination risks are identified and controlled by design, and that enterprise standards align with applicable regulatory expectations, including EU GMP Annex 1 (2022), FDA guidance, and ISO standards.

The position leads and supports risk assessments, quality impact assessments, complex Business Technical Assessments, regulatory inspection readiness, and responses to systemic aseptic and microbial control issues. It partners with Engineering, Validation, MS&T, Operations, Regulatory, and other functions to establish design standards, qualification requirements, contamination control strategies, sterilization standards, and single-use technology qualification approaches. The role requires up to 25% travel.

Requirements

• B.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, or a related scientific discipline.
• 10+ 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 designing or overhauling APS/media fill programs or contamination control strategy frameworks at a 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 (2022), 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.

Nice To Haves

• M.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, or a related scientific discipline.

Responsibilities

• Review and approve global risk assessments and quality impact assessments associated with contamination events and microbial control failures involving Facilities & Utilities.
• Lead and author high-complexity Business Technical Assessments to support regulatory submissions, systemic issue resolution, and cross-site technical alignment involving Facilities & Utilities.
• 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.
• Serve as the Global Quality SME for aseptic facility and utility design, reviewing and approving 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 by-design oversight for facility, utility, and equipment changes, identifying, assessing, and controlling microbial and particulate contamination risks during design.
• Serve as technical authority for aseptic design principles during capital projects, facility modifications, and technology transfers, incorporating contamination control strategy requirements into design specifications.
• Provide Quality oversight for Water for Injection, Purified Water, clean steam, clean compressed gases, and HVAC/clean air systems, including design, qualification, and ongoing microbial and chemical control requirements.
• Partner with Engineering and Validation to ensure IQ/OQ/PQ programs demonstrate microbiological and contamination control performance against defined acceptance criteria.
• Champion Quality by Design and risk-based thinking throughout facility and equipment lifecycle management.
• Oversee aseptic facility and utility design standards at external manufacturing partners, reviewing design packages, contamination control strategy documentation, and utility qualification strategies as required.
• Support quality risk assessments of external manufacturing partner facility and utility designs, identify gaps against BMS standards and regulatory expectations, and drive remediation through the ExM quality governance framework.
• Own development and governance of enterprise design standards for sterilization technologies, including single-use technology and consumable qualification.
• Define sterilization validation requirements and risk-based bioburden control strategies for components, containers, and sterile fluid pathways, supporting MS&T and Engineering design decisions.
• Ensure sterilization design standards remain current with regulatory guidance and industry practices.
• Travel up to 25%.

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 without a set accrual limit for eligible U.S.-based exempt employees, subject to manager approval.
• 11 paid company holidays annually.
• Eligible non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires, subject to manager approval, plus 11 paid company holidays and 3 optional holidays.
• Depending on eligibility, paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs.
• Eligible employees receive an annual Global Shutdown between Christmas Day and New Year's Day.
• Potential eligibility for additional discretionary incentive cash and stock opportunities.

What This Job Offers

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