Associate Director, Aseptic Facility and Utility Design

Role: Associate Director specializing in aseptic facility and utility design within biopharma manufacturing, focusing on contamination prevention and microbial control. Responsibilities: review and approve risk assessments and quality impact assessments related to contamination events; lead technical assessments for regulatory submissions; develop investigation and inspection readiness documentation; serve as SME on aseptic design standards, review design packages, and ensure compliance with global regulations (EU GMP Annex 1, FDA guidance, ISO standards); oversee design standards for sterilization and single-use technologies; partner across Quality, Engineering, MS&T, and Regulatory teams; support facility modifications and technology transfers; provide oversight during audits and inspections. Qualifications: B.S. in Microbiology, Pharmaceutical Sciences, Biology, or related field; 10+ years in sterility assurance, microbiology, or pharmaceutical quality, with at least 4 years in leadership roles; deep expertise in aseptic processing, environmental monitoring, contamination control, sterilization validation, and single-use systems; strong knowledge of regulatory guidance (FDA, EU, PDA, ISO); skilled in risk assessment methodologies, facility design standards, and contamination control strategies. Travel: up to 25%. High-value biopharma specifics: focus on sterile manufacturing facilities, aseptic processing, microbiological risk assessments, and compliance with global aseptic processing standards, supporting biologics or sterile product manufacturing.