Sterility Assurance Lead

Job detailsThe 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.Location: Raleigh NCSalary: $90,000-$110,000/yearDirect Hire roleKey ResponsibilitiesSterility Assurance & Contamination ControlDevelop, implement, and maintain sterility assurance and contamination control programs for sterile manufacturing operationsLead the site Contamination Control Strategy (CCS) and ensure alignment with regulatory expectations and industry best practicesServe as SME for sterility assurance, microbiological oversight, and contamination control activitiesDefine and monitor microbiological and particulate alert/action limitsEnsure environmental monitoring programs are effectively designed, executed, evaluated, and maintained throughout the product lifecycleSupport inspection readiness and participate in regulatory inspections and audits as the sterility assurance SMEPrepare and support responses to regulatory observations related to sterility assurance and contamination control Process Oversight, Validation & QualificationProvide oversight for terminal sterilization and aseptic manufacturing processes across development, validation, and commercial operationsReview and approve critical manufacturing and sterilization activities including washing, filling, sterilization cycles, and environmental controlsReview and approve validation strategies, protocols, and reports including IQ/OQ/PQ activitiesEnsure appropriate microbiological and particulate control strategies are established and maintainedSupport ongoing process verification and continued process monitoring activities Investigations, Risk Assessment & CAPALead or support investigations involving microbiological deviations, contamination events, and sterility-related nonconformancesConduct and review risk assessments related to sterility assurance and contamination controlDrive development and implementation of CAPAs to mitigate contamination and sterility risksMonitor trends and recurring issues to identify and address systemic risks Cross-Functional Collaboration & TrainingPartner with Manufacturing, Engineering, Validation, Quality Control Microbiology, and Quality Assurance teams to ensure effective sterility assurance integrationProvide coaching, training, and guidance on contamination control principles, aseptic behaviors, and sterility assurance best practicesSupport development and revision of SOPs, work instructions, and training materialsPromote a strong quality culture focused on compliance, contamination control, and operational excellence Continuous Improvement & Operational SupportParticipate in operational excellence and continuous improvement initiativesSupport technology transfers, new product introductions, and cross-functional projectsAssist with internal audits, gap assessments, and periodic reviews of sterility assurance systemsSupport departmental and site objectives as assigned QualificationsEducationBachelor's or Master's degree in Microbiology, Pharmaceutical Sciences, Biotechnology, Engineering, or related scientific discipline ExperienceMinimum 5 years of experience in sterile pharmaceutical manufacturing, injectable products, or terminal sterilization environmentsExperience supporting aseptic processing and/or terminal sterilization operationsStrong knowledge of microbiology principles, contamination control, and cleanroom manufacturingExperience supporting validation, qualification, and regulatory compliance activities