Senior Sterility Assurance Specialist — Microbiology

Planet Pharma; Berkeley (CA); On-site; USD 59,000 - 73,000; Full time

Job summary

Planet Pharma's Berkeley site seeks a Sterility Assurance Specialist to provide senior microbiology and aseptic processing expertise to support the site’s Sterility Assurance and Contamination Control Program. You’ll focus on environmental monitoring, personnel monitoring, organism trends, and contamination investigations.

This contract role emphasizes interpreting microbial data, supporting APS/media fill assessments, CAPA effectiveness, risk assessments, and development of site standards and

Qualifications

• Bachelor's degree in microbiology or related life sciences.
• 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 knowledge 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

Environmental monitoring

Aseptic processing

Microbiology

Technical writing

Cross-functional communication

Education

Bachelor's degree in Microbiology

Job description

Planet Pharma's Berkeley site seeks a Sterility Assurance Specialist to provide senior microbiology and aseptic processing expertise to support the site’s Sterility Assurance and Contamination Control Program. You’ll focus on environmental monitoring, personnel monitoring, organism trends, and contamination investigations.

This contract role emphasizes interpreting microbial data, supporting APS/media fill assessments, CAPA effectiveness, risk assessments, and development of site standards and