Sterility Assurance Lead

The Sterility Assurance Lead is responsible for leading and maintaining site-wide sterility assurance and contamination control programs within a sterile pharmaceutical manufacturing environment. This role provides technical leadership and oversight for terminally sterilized and injectable drug product operations, ensuring compliance with FDA aseptic processing guidance, EU Annex 1, cGMP standards, and global regulatory requirements. The position serves as the site Subject Matter Expert (SME) for sterility assurance, environmental monitoring, microbiological risk management, and contamination control strategies while supporting process validation, regulatory inspections, and continuous improvement initiatives. No relocation assistance offered Key Responsibilities Sterility Assurance & Contamination Control Develop, implement, and maintain sterility assurance and contamination control programs for sterile manufacturing operation Lead the site Contamination Control Strategy (CCS) and ensure alignment with regulatory expectations and industry best practice Serve as SME for sterility assurance, microbiological oversight, and contamination control activities Define and monitor microbiological and particulate alert/action limits Ensure environmental monitoring programs are effectively designed, executed, evaluated, and maintained throughout the product lifecycle Support inspection readiness and participate in regulatory inspections and audits as the sterility assurance SM Prepare and support responses to regulatory observations related to sterility assurance and contamination control Process Oversight, Validation & Qualification Provide oversight for terminal sterilization and aseptic manufacturing processes across development, validation, and commercial operation Review and approve critical manufacturing and sterilization activities including washing, filling, sterilization cycles, and environmental control Review and approve validation strategies, protocols, and reports including IQ/OQ/PQ activities Ensure appropriate microbiological and particulate control strategies are established and maintained Support ongoing process verification and continued process monitoring activities Lead or support investigations involving microbiological deviations, contamination events, and sterility-related nonconformance Conduct and review risk assessments related to sterility assurance and contamination control Drive development and implementation of CAPAs to mitigate contamination and sterility risk Monitor trends and recurring issues to identify and address systemic risk Cross-Functional Collaboration & Training Partner with Manufacturing, Engineering, Validation, Quality Control Microbiology, and Quality Assurance teams to ensure effective sterility assurance integration Provide coaching, training, and guidance on contamination control principles, aseptic behaviors, and sterility assurance best practice Support development and revision of SOPs, work instructions, and training material Promote a strong quality culture focused on compliance, contamination control, and operational excellence Continuous Improvement & Operational Support Participate in operational excellence and continuous improvement initiatives Support technology transfers, new product introductions, and cross-functional projects Assist with internal audits, gap assessments, and periodic reviews of sterility assurance system Support departmental and site objectives as assigned Qualifications Education Bachelor’s or Master’s degree in Microbiology, Pharmaceutical Sciences, Biotechnology, Engineering, or related scientific discipline Experience Minimum 5 years of experience in sterile pharmaceutical manufacturing, injectable products, or terminal sterilization environment Experience supporting aseptic processing and/or terminal sterilization operation Strong knowledge of microbiology principles, contamination control, and cleanroom manufacturing Experience supporting validation, qualification, and regulatory compliance activities #J-18808-Ljbffr Kelly Science, Engineering, Technology & Telecom