Sterility Assurance Specialist (Mid) – Microbiology Contract

Bayer AG; Berkeley (CA); On-site; USD 66,000 - 110,000; Full time

Job summary

Bayer AG - US site seeks a mid-level, contract Sterility Assurance Specialist to provide microbiology expertise for Berkeley operations. The role emphasizes environmental monitoring, contamination investigations, and risk assessments within GMP frameworks.

The contractor will support ventilation/system data reviews, CAPAs, and cross-functional collaboration to strengthen sterility assurance and contamination control programs.

Qualifications

• 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.

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.

Skills

Sterility assurance

Microbiology

Environmental monitoring

Aseptic processing

GMP deviations / CAPA

Education

Bachelor’s degree in microbiology or related field

Job description

Bayer AG - US site seeks a mid-level, contract Sterility Assurance Specialist to provide microbiology expertise for Berkeley operations. The role emphasizes environmental monitoring, contamination investigations, and risk assessments within GMP frameworks.

The contractor will support ventilation/system data reviews, CAPAs, and cross-functional collaboration to strengthen sterility assurance and contamination control programs.