Associate Director, Aseptic Facility and Utility Design
Core
Global Quality SME for aseptic facility and utility design, defining enterprise standards and overseeing contamination control strategies for cleanrooms, barrier systems, and critical utilities.
Role type
Senior IC pharmaceutical quality engineer (aseptic facility design)
Builds
Aseptic facility design packages, User Requirement Specifications (URS), and contamination control strategies for sterile manufacturing sites.
Domain
Pharmaceutical manufacturing / Aseptic processing / Facility design
Required skills
Aseptic processing regulations (EU GMP Annex 1, FDA Aseptic Processing Guidance), Contamination Control Strategy (CCS) development, Risk assessment (FMEA, HACCP), Cleanroom classification and airflow design, Sterilization validation (EtO, gamma, steam), Single-use technology (SUT) qualification, Regulatory inspection defense (FDA, EMA)
Preferred skills
M.S. in Microbiology or Pharmaceutical Sciences, Experience with ExM partners (CMOs/CDMOs) oversight
Technologies
EU GMP Annex 1 (2022), ISO 14644 series, USP <1116>, PDA Technical Reports (TR22, TR13, TR70, TR90), FMEA, HACCP, Fault tree analysis
Responsibilities
Review and approve global risk assessments and quality impact assessments for contamination events; Lead and author high-complexity Business Technical Assessments (BTAs) for regulatory submissions; Define enterprise-level Quality standards for aseptic facility design including cleanroom classification and airflow; Provide by-design oversight for facility and utility changes to control microbial risks; Partner with Engineering and Validation teams to ensure facility qualification programs demonstrate contamination control performance; Champion Quality by Design (QbD) across the facility lifecycle; Provide oversight of aseptic design standards at external manufacturing partners; Own the development of enterprise design standards for sterilization technologies and single-use systems.
Seniority
Senior, leadership/enterprise-level role