Sterility Assurance Specialist (HYBRID)

We're hiring a Sterility Assurance Specialist to strengthen contamination control and sterility assurance programs within a biologics/cell therapy manufacturing operation. This is a senior individual contributor role for a microbiology expert who can lead investigations, interpret trends, and drive practical, risk-based recommendations across a sterile manufacturing environment.What you'll do:Support investigations into environmental excursions, personnel monitoring recoveries, bioburden events, and recurring organism trendsPerform microbiological risk assessments across aseptic processing, cleanroom operations, cleaning/disinfection, utilities, and personnel practicesReview microbial ID results to assess likely sources — human flora, water-associated organisms, spore-formers, and objectionable organismsSupport Grade A/B/C/D contamination investigations, pulling in EM data, cleaning history, maintenance, and intervention recordsPartner with QC Microbiology and QC EM teams to spot adverse trends across locations, operators, and organismsSupport APS/media fill assessments — contamination events, intervention representativeness, CAPA effectivenessContribute microbiological rationale and root cause input to deviations and CAPAsHelp build decision trees, training materials, and technical guidance for contamination controlCollaborate closely with QC, Manufacturing, QA, Engineering, and ValidationWhat you bring:5+ years in QC Microbiology, environmental monitoring, aseptic processing, contamination control, or biologics/cell therapy manufacturingGrade A/B aseptic processing, sterile drug product, or cell therapy experience preferredExperience with APS/media fills, gowning qualification, aseptic behavior observations, or disinfectant efficacy a plusSolid grasp of GMP deviations, CAPAs, root cause analysis, and risk management principlesBachelor's degree in Microbiology, Biology, Biotechnology, Pharmaceutical Sciences, or related fieldFamiliarity with EU GMP Annex 1, FDA aseptic processing guidance, USP microbiology chapters, PDA technical reports, and ICH Q9/Q10HarveStaff LLC is an Equal Opportunity Employer.JOB-10047599