Associate Director, Aseptic Facility and Utility Design

Role: Associate Director overseeing aseptic facility and utility design to ensure microbial and contamination control in pharmaceutical manufacturing. Responsibilities: review and approve risk assessments, lead technical assessments for regulatory submissions, develop inspection-readiness materials, and serve as SME for aseptic design standards. Provide oversight on facility, utility, and equipment changes, including sterile systems like WFI, clean steam, and HVAC, ensuring compliance with EU GMP Annex 1, FDA guidance, and ISO standards. Lead sterilization standards governance, including SUT and validation strategies. Qualifications: B.S. in Microbiology, Pharmaceutical Sciences, Biology, or related field; 10+ years in sterility assurance, microbiology, or aseptic manufacturing, with at least 4 years in leadership. Skills include expertise in aseptic processing regulations, contamination control, sterilization methods, and risk assessment methodologies. HighValue: focus on aseptic facilities, microbial risk management, sterile manufacturing, regulatory inspection readiness, and design standards for biologics or sterile products. Travel up to 25%. Preferred: M.S. degree.