Associate Director, Aseptic Facility and Utility Design

Role: Associate Director, Aseptic Facility and Utility Design, leading global quality strategies for aseptic manufacturing environments within biopharma. Responsibilities: review and approve risk assessments, lead complex business technical assessments supporting regulatory submissions, and serve as SME for aseptic facility and utility design standards. Oversee design qualification, change control, and microbial control strategies for sterile facilities, utilities (e.g., WFI, clean steam), and single-use technologies. Ensure compliance with EU GMP Annex 1, FDA guidance, and industry standards; collaborate with Engineering, Validation, and external partners; provide inspection readiness and support regulatory audits. Qualifications: B.S. in Microbiology, Pharmaceutical Sciences, Biology, or related field; 10+ years in sterility assurance, microbiology, or pharmaceutical quality; at least 4 years in leadership roles within regulated pharma environments. Skills: deep expertise in aseptic processing, environmental monitoring, contamination control, sterilization validation, risk assessment methodologies (FMEA, HACCP), and facility design standards. High-value biopharma specifics: focus on sterile manufacturing, biologics, and advanced aseptic techniques; involvement in design, qualification, and risk management of facilities and utilities; up to 25% travel. Work setup: based in the U.S. with multiple location options.