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 in pharmaceutical manufacturing.
Role type
Senior IC pharmaceutical quality specialist (aseptic facility design)
Builds
Aseptic facility design packages, User Requirement Specifications (URS), design qualification protocols, and contamination control strategies for sterile manufacturing sites.
Domain
Pharmaceutical manufacturing / Biologics / Aseptic processing
Required skills
Aseptic processing regulations (FDA, EU GMP Annex 1), Contamination Control Strategy (CCS) development, Risk assessment (FMEA, HACCP), Cleanroom classification and airflow design, Sterilization validation (EtO, gamma, steam), Microbial risk assessment
Preferred skills
M.S. in Microbiology or Pharmaceutical Sciences
Technologies
EU GMP Annex 1, FDA Aseptic Processing Guidance, ISO 14644, ISO 11135, ISO 11137, USP, PDA Technical Reports
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; Serve as technical authority for aseptic design principles during capital projects and technology transfers; Provide Quality oversight for critical utility systems (WFI, PW, clean steam, HVAC); Partner with Engineering and Validation teams to ensure facility qualification programs demonstrate microbiological performance; Champion Quality by Design (QbD) across facility lifecycle management; Provide oversight of design standards at ExM partners (CMOs/CDMOs).
Seniority
Senior, hands-on IC