Associate Director, Aseptic Facility and Utility Design

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)

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 clean rooms, 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

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

10+ years of progressive experience in…