Sterility Assurance Specialist
TekWissen•Berkeley, CA
•Hybrid
About The Position
The Sterility Assurance Specialist will provide senior individual contributor microbiology and aseptic processing expertise to support the Berkeley Site Sterility Assurance and Contamination Control Program. This contract role will focus on environmental monitoring reports, personnel monitoring, organism trends, microbial contamination investigations, APS/media fill support, microbial risk assessments, and contamination control effectiveness. The role will help ensure that microbial data and contamination events are interpreted as part of an integrated sterility assurance and contamination control strategy. This position is an individual contributor specialist role and does not include people management responsibilities.
Requirements
- Bachelor's degree in microbiology, biology, biotechnology, pharmaceutical sciences, or a related scientific discipline.
- Minimum 5 years of relevant experience in QC Microbiology, environmental monitoring, sterile manufacturing support, aseptic processing, contamination control, sterility assurance, or biologics/cell therapy manufacturing.
- Strong understanding of environmental monitoring, personnel monitoring, microbial identification, bioburden, aseptic technique, cleanroom controls, and contamination investigations.
- Experience supporting GMP deviations, CAPAs, root cause analysis, risk assessments, and technical documentation.
- Ability to interpret microbial data and translate findings into practical contamination control recommendations.
- Strong technical writing and cross-functional communication skills.
Nice To Haves
- Experience with Grade A/B aseptic processing, biologics, cell therapy, sterile drug product, or sterile manufacturing operations.
- Experience with APS/media fills, gowning qualification, operator monitoring, aseptic behavior observations, disinfectant efficacy, cleaning/disinfection programs, or contamination recovery investigations.
- Familiarity with EU GMP Annex 1, FDA aseptic processing guidance, USP microbiology chapters, PDA technical reports, and ICH Q9/Q10.
- Experience with microbial source tracking, recurring organism assessments, objectionable organism rationale, or biofilm-related investigations.
- Experience working with QC Microbiology, Manufacturing, QA, Engineering, and Validation teams.
Responsibilities
- Provide technical support for assessment of microbial contamination events, EM excursions, personnel monitoring recoveries, bioburden events, sterility assurance signals, and recurring organism patterns.
- Perform microbiological risk assessments related to aseptic processing, cleanroom operations, material transfer, cleaning/disinfection, utilities, interventions, personnel practices, and contamination control gaps.
- Review microbial identification results and support interpretation of organism source plausibility, including human flora, water-associated organisms, spore-formers, environmental organisms, objectionable organisms, and recurring isolates.
- Support investigation of Grade A/B/C/D contamination events, including review of EM data, personnel monitoring, process observations, cleaning history, maintenance activities, material flow, intervention records, and facility/utility conditions.
- Partner with QC Microbiology and QC EMO to identify adverse trends, recurring locations, recurring operators, recurring organisms, and cross-area contamination signals that may require escalation to CCS, QRM, or Site Quality governance.
- Support APS/media fill assessments by evaluating contamination events, intervention representativeness, personnel participation, recurring failure modes, and CAPA effectiveness.
- Assist with development of risk-based escalation criteria for EM/personnel monitoring trends, microbial IDs, contamination-related deviations, and repeat events.
- Review contamination-related deviations and CAPAs, as assigned, to provide microbiological rationale, root cause assessment input, risk impact assessment, and effectiveness-check recommendations.
- Contribute to periodic Sterility Assurance health summaries by assessing microbial risk signals, repeat contamination patterns, investigation quality, and CAPA effectiveness.
- Support development of site standards, decision trees, training content, and technical guidance related to microbial contamination control.
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What This Job Offers
Career Level
Senior
