Principal Sterility Assurance & Contamination Control Specialist

Principal Sterility Assurance & Contamination Control Specialist

Required Education: Bachelor's degree in Microbiology, Biology, Biotechnology, Engineering, Pharmaceutical Sciences or a related scientific/technical field.

Required Qualifications: 8+ years of experience in pharmaceutical, biotechnology, biologics, sterile manufacturing, cell therapy, aseptic processing or a related GMP environment. Experience supporting sterility assurance, contamination control, quality systems, validation, QC Microbiology, manufacturing technical support or GMP program execution. Strong knowledge of GMP quality systems, deviations, CAPA, change control, risk management and inspection readiness. Demonstrated experience coordinating cross-functional programs, action trackers, dashboards, risk registers and leadership updates. Experience partnering with Quality, QC Microbiology, Manufacturing, Engineering, Validation, Facilities, MSAT or Technical Operations. Strong technical writing, organization, facilitation and communication skills.

Preferred Qualifications: Experience developing, implementing or reviewing a Contamination Control Strategy. Experience with aseptic manufacturing, environmental monitoring, APS/media fills, cleaning and disinfection, microbial investigations or facility contamination control. Knowledge of EU GMP Annex 1, FDA aseptic processing guidance, ICH Q9/Q10, PDA technical reports and cleanroom standards. Experience supporting regulatory inspections, audit responses or inspection-readiness programs. Experience with FMEA, HACCP, fault-tree analysis, risk registers or other risk-based assessment methodologies.

Summary: Seeking an experienced Principal Sterility Assurance & Contamination Control Specialist to support the Berkeley site's Sterility Assurance and Contamination Control Program. This senior individual contributor role will help drive the site's Contamination Control Strategy (CCS), program governance, risk management, metrics, action tracking and inspection readiness. The successful candidate will work across Quality, QC Microbiology, Manufacturing, Engineering, Validation, Facilities, MSAT/Technical Operations and Quality Risk Management to turn complex contamination-control risks into clear action plans, governance decisions and measurable improvements. This position does not have direct people-management responsibilities.

Responsibilities: Support implementation and continued maturity of the Berkeley site's Sterility Assurance and Contamination Control Program. Maintain the site CCS roadmap and action tracker, including owners, deadlines, dependencies, risk rankings, progress and escalation requirements. Prepare materials for Sterility Assurance governance meetings, including agendas, action logs, decision records, risk summaries and leadership updates. Partner with Quality Risk Management stakeholders to document, prioritize and escalate contamination-control risks. Integrate relevant data from Quality, QC Microbiology, Manufacturing, Engineering, Validation and Operations to support meaningful sterility assurance metrics. Develop periodic Sterility Assurance and Contamination Control health summaries covering high-risk gaps, overdue actions, contamination trends, CAPA effectiveness and inspection readiness. Support inspection-readiness activities involving CCS, contamination-control governance, risk-based decisions, CAPA tracking and program maturity. Develop and improve program tools such as charters, templates, decision trees, risk-review forms, dashboards and governance materials. Coordinate complex deliverables across multiple technical and quality functions while maintaining strong documentation and follow-through. Identify risks, barriers and overdue activities and ensure appropriate escalation and resolution.

**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.