Sterility Assurance Lead

Job Title: Sterility Assurance LeadLocation: Raleigh (Onsite)Compensation:$105,000 - $125,000 base salary (flexible based on experience) + bonus potentialPosition OverviewWe are seeking a Sterility Assurance Lead to own and drive the site's sterility assurance strategy for sterile injectable products manufactured in classified environments with terminal sterilization processes. This is a high-impact role responsible for contamination control, microbiological oversight, and regulatory readiness in alignment with FDA guidance and EU GMP Annex 1.This individual will serve as the site Subject Matter Expert (SME) and play a critical role in ensuring inspection readiness, advancing contamination control strategies, and continuously improving sterility assurance systems.Key ResponsibilitiesSterility Assurance & Contamination ControlLead and maintain the site-wide sterility assurance programOwn and continuously improve the Contamination Control Strategy (CCS)Establish and monitor microbiological and particulate limitsEnsure alignment with FDA aseptic processing guidance and EU Annex 1Serve as SME during regulatory inspections and auditsEnvironmental Monitoring & Program OwnershipOwn the Environmental Monitoring Performance Qualification (EMPQ) programOversee lifecycle management including design, execution, trending, and optimizationEnsure effectiveness of environmental monitoring and contamination controlsProcess Oversight & ValidationProvide sterility assurance oversight across the product lifecycleReview and approve critical processes (washing, filling, sterilization)Approve validation strategies and documentation (IQ/OQ/PQ)Ensure robust contamination control prior to sterilizationInvestigations, Risk & CAPALead investigations related to contamination events and microbiological deviationsPerform risk assessments using structured tools (FMEA, HACCP)Implement and monitor corrective and preventive actions (CAPA)Identify trends and drive systemic improvementsCross-Functional LeadershipPartner with Production, Engineering, QC Microbiology, Validation, and QAProvide training on aseptic practices and contamination controlDrive a strong quality and sterility assurance culture across the siteQualificationsRequiredBachelor's or Master's degree in Microbiology, Pharmaceutical Sciences, Biotechnology, Engineering, or related field5+ years of experience in sterile or injectable pharmaceutical manufacturingExperience with terminal sterilization and/or aseptic processingStrong knowledge of microbiology and contamination control principlesExperience working in cleanroom environmentsPreferredExperience supporting FDA or international regulatory inspectionsExperience with EU GMP Annex 1 implementation or remediation

Created: 2026-05-08