Associate Director, Aseptic Facility and Utility Design
Core
Lead global quality governance and design standards for aseptic facilities, utilities, and sterilization technologies to ensure compliance with EU GMP Annex 1 and FDA regulations.
Role type
Senior IC pharmaceutical quality director (aseptic facility design)
Builds
Enterprise-level quality standards, design qualification protocols, and contamination control strategies for sterile manufacturing sites and CDMOs.
Domain
Pharmaceutical manufacturing / Aseptic processing / Facility design
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Aseptic processing regulations (EU GMP Annex 1, FDA Aseptic Processing Guidance), Contamination Control Strategy (CCS) development, Risk assessment methodologies (FMEA, HACCP, fault tree analysis), Sterilization validation (EtO, gamma, steam, VHP), Cleanroom classification and airflow design, Regulatory inspection defense (FDA/EMA), Single-use technology (SUT) qualification
Preferred skills
M.S. in Microbiology or Pharmaceutical Sciences, Experience designing APS/media fill programs
Technologies
None explicitly listed as tools/frameworks
Responsibilities
Review and approve global risk assessments and quality impact assessments for contamination events, Lead high-complexity Business Technical Assessments (BTAs) for regulatory submissions, Serve as Global Quality SME for aseptic facility and utility design, Define enterprise-level quality standards for cleanroom classification and airflow, Provide oversight for facility and utility changes to control microbial risks, Partner with Engineering to ensure facility qualification programs demonstrate contamination control performance, Champion Quality by Design (QbD) across facility lifecycle, Support quality risk assessments of ExM partner facility designs, Own development of enterprise design standards for sterilization technologies and SUT, Define sterilization validation requirements and bioburden control strategies
Seniority
Senior, leadership/enterprise-level role
