Associate Director, Aseptic Facility and Utility Design

Key Responsibilities

Risk Assessment & Quality Impact Governance

• Review and approve global risk assessments and quality impact assessments (QIAs) associated with contamination events and microbial control failures around Facilities & Utilities.
• Lead and author high-complexity Business Technical Assessments (BTAs) to support regulatory submissions, systemic issue resolution, and cross-site technical alignment when associated with Facilities & Utilities.
• Develop and maintain comprehensive investigation and inspection-readiness materials for systemic aseptic and microbial control issues, serving as a subject matter expert on BMS Facilities & Utilities during regulatory inspections (FDA, EMA, and other health authorities).

Aseptic & Microbial Control by Design

• Serve as the Global Quality SME for aseptic facility and utility design, providing expert review and approval of design packages, User Requirement Specifications (URS), design qualification (DQ) protocols, and change controls associated with cleanrooms, barrier systems (RABS/isolators), and critical utilities.
• Define and maintain enterprise-level Quality standards and requirements for aseptic facility and utility design, including cleanroom classification, airflow and pressure differential design, surface finish specifications, and drainability — ensuring alignment with EU GMP Annex 1 (2022), FDA Aseptic Processing Guidance, and ISO 14644 series.
• Provide by-design oversight for facility, utility and equipment changes — both sterile and non-sterile — ensuring microbial and particulate contamination risks are systematically identified, assessed, and controlled at the design stage.
• Serve as the technical authority for aseptic design principles during capital projects, facility modifications, and technology transfers, integrating contamination control strategy (CCS) requirements into design specifications.
• Provide Quality oversight for critical utility systems — including Water for Injection (WFI), Purified Water (PW), clean steam, clean compressed gases, and HVAC/clean air systems — covering design, qualification, and ongoing microbial and chemical control requirements.
• Partner with Engineering and Validation teams to ensure facility and utility qualification (IQ/OQ/PQ) programs adequately demonstrate microbiological and contamination control performance against defined acceptance criteria.
• Champion Quality by Design (QbD) and risk-based thinking across all phases of facility and equipment lifecycle management.
• Provide oversight of aseptic facility and utility design standards at ExM partners (CMOs/CDMOs), reviewing facility design packages, CCS documentation, and utility qualification strategies as part of site qualification and ongoing oversight programs, as required.
• Support quality risk assessments of ExM facility and utility design, identifying gaps relative to BMS standards and current regulatory expectations, and driving remediation through the ExM quality governance framework.

Sterilization Standards & Single-Use Technology (SUT)

• Own the development and governance of enterprise design standards for sterilization technologies, with expertise in single-use technology (SUT) and consumable qualification.
• Define sterilization validation requirements and risk-based bioburden control strategies for components, containers, and sterile fluid pathways, supporting both MS&T and Engineering in design decisions.
• Ensure sterilization design standards remain current with evolving regulatory guidance (e.g., ISO 11135, ISO 11137, ISO 11040) and industry best practices.

Qualifications & Experience

Education Required: B.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, or a related scientific discipline.

Experience: 10+ years of progressive experience in sterility assurance, aseptic manufacturing, microbiology, or pharmaceutical quality — with at least 4 years in a leadership or enterprise-level role.

• Deep technical expertise in aseptic processing, environmental monitoring, contamination control, and microbial risk assessment within a regulated pharmaceutical or biologics manufacturing environment.
• Demonstrated experience authoring and defending technical positions during regulatory inspections (FDA PAI/GMP, EMA, PMDA).
• Proven track record in designing or overhauling APS/media fill programs or CCS frameworks at a network or enterprise scale.
• Hands-on experience with sterilization validation and single-use system qualification.

Skills & Competencies

• Expert-level knowledge of aseptic processing regulations and guidance: FDA Aseptic Processing Guidance (2004/Revised), EU GMP Annex 1 (2022), USP , ISO 13408 series, PDA Technical Reports (TR22, TR13, TR70, TR90).
• Strong command of contamination control strategy (CCS) development as required under EU GMP Annex 1.
• Proficiency in risk assessment methodologies: FMEA, HACCP, fault tree analysis, risk ranking and filtering.
• Familiarity with facility design standards, cleanroom classification, and airflow visualization techniques.
• Experience with sterilization technologies: EtO, gamma, steam (moist heat), dry heat, and VHP/HPV.
• Strong cross-functional partnership skills across Quality, Operations, MS&T, Regulatory, and Supply Chain.

Travel: This position requires up to 25% of travel.

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