NEW JOB OPENING
STERILITY ASSURANCE SPECIALIST -GMP MICROBIOLOGY & ASEPTIC PROCESSING
IN Berkeley, CA, USA!

REQUIRED EDUCATION

• Bachelor's degree in Microbiology, Biology, Biotechnology, Pharmaceutical Sciences, or a related scientific discipline.



REQUIRED QUALIFICATIONS

• Minimum 5 years of relevant experience in QC Microbiology, environmental monitoring, sterile manufacturing, aseptic processing, contamination control, sterility assurance, biologics, or a related GMP environment.

• Strong knowledge of environmental monitoring, personnel monitoring, microbial identification, bioburden, aseptic technique, cleanroom controls, and microbial 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.



PREFERRED QUALIFICATIONS

• Experience with Grade A/B aseptic processing, biologics, cell therapy, sterile drug product, or sterile manufacturing.

• Experience with APS/media fills, gowning qualification, operator monitoring, aseptic behavior observations, disinfectant efficacy, or cleaning/disinfection programs.

• 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 evaluations, or biofilm investigations.

• Experience partnering with QC Microbiology, Manufacturing, QA, Engineering, and Validation.



SUMMARY



Seeking an experienced Sterility Assurance Specialist to support the Berkeley site's Sterility Assurance and Contamination Control Program.



This is a senior individual contributor role for a microbiology professional with strong experience in GMP manufacturing, environmental monitoring, aseptic processing, contamination investigations, and microbiological risk assessment.



The specialist will evaluate microbial data and contamination events and help translate those findings into practical contamination-control strategies. The role will work closely with QC Microbiology, Quality, Manufacturing, Engineering, Validation, and other site functions.



RESPONSIBILITIES

• Evaluate microbial contamination events, environmental monitoring excursions, personnel monitoring recoveries, bioburden events, and recurring organism trends.

• Perform microbiological risk assessments related to aseptic processing, cleanroom operations, material transfers, cleaning and disinfection, utilities, personnel practices, and contamination-control gaps.

• Review microbial identification results and assess potential organism sources, including human flora, water-associated organisms, spore-formers, environmental organisms, and recurring isolates.

• Support investigations involving Grade A/B/C/D contamination events by reviewing EM data, personnel monitoring, process observations, cleaning history, maintenance activities, material flow, interventions, and facility/utilities conditions.

• Identify adverse microbial trends, recurring locations, recurring operators, recurring organisms, and potential cross-area contamination signals.

• Support APS/media fill assessments, including contamination events, intervention representativeness, personnel participation, recurring failure modes, and CAPA effectiveness.

• Provide microbiological input into GMP deviations, CAPAs, root cause investigations, and risk assessments.

• Help establish risk-based escalation criteria for environmental/personnel monitoring trends, microbial identifications, contamination-related deviations, and repeat events.

• Contribute to Sterility Assurance health summaries and evaluate recurring contamination patterns, investigation quality, and CAPA effectiveness.

• Develop or contribute to site standards, technical guidance, decision trees, and training related to microbial contamination control.

• Collaborate with QC Microbiology, QA, Manufacturing, Engineering, Validation, and Facilities teams to strengthen site contamination-control practices.



***Drug screen & criminal background check will be required

• **Only those lawfully authorized to work in the designated country associated with the position will be considered.**

• **Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client’s business needs and requirements.**