Associate Director, Aseptic Facility and Utility Design

Role: Associate Director specializing in aseptic facility and utility design, focusing on contamination control, risk assessments, and regulatory compliance within biologics manufacturing. Responsibilities: review and approve global risk assessments and quality impact assessments related to contamination events; lead high-complexity Business Technical Assessments supporting regulatory submissions; develop investigation and inspection-readiness materials; serve as SME on aseptic design principles, facility qualifications, and contamination prevention strategies; oversee utility systems and sterilization standards, including single-use technologies, ensuring compliance with EU GMP Annex 1 (2022), FDA, ISO, and other standards; collaborate with engineering, validation, and external partners for design, qualification, and risk mitigation. 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 or enterprise roles; deep expertise in aseptic processing, contamination control, sterilization validation, and regulatory inspection readiness. Skills: advanced knowledge of aseptic processing regulations, risk assessment methodologies, facility design standards, sterilization technologies (EtO, gamma, steam, VHP/HPV); strong cross-functional partnership skills. Travel: up to 25%. High-value: biologics manufacturing, aseptic and microbial control, risk assessments, regulatory inspections, sterile utilities, single-use technology, GMP compliance, global collaboration.