Senior Sterility Assurance Specialist — Contamination Control

Planet Pharma; Berkeley (CA); On-site; USD 69,000 - 83,000; Full time

Job summary

Planet Pharma in Berkeley seeks a Sterility Assurance Principal Specialist to provide senior, individual contributor support across the Contamination Control program. You will translate strategy into practical deliverables, governance materials, risk docs, and action plans with Quality, QC Microbiology, Manufacturing, Engineering, Validation, Facilities, MSAT, and QRM.

This role emphasizes governance, risk documentation, inspection readiness, and metrics development without people management

Qualifications

• Bachelor's degree in microbiology, biology, biotechnology, engineering, pharmaceutical sciences, or a related field.
• Minimum 8 years of experience in pharma/biotech/sterile manufacturing environments.
• Experience supporting contamination control, sterility assurance, quality systems, validation, and GMP program execution.

Responsibilities

• Support implementation of the Berkeley Site Sterility Assurance and Contamination Control Program, including roadmap and governance materials.
• Maintain the site action tracker with owners, due dates, dependencies, and risk ranking.
• Prepare Sterility Assurance Council materials including agendas and logs.
• Collaborate with QRM to document and prioritize contamination control risks.
• Develop site-level sterility assurance metrics by integrating data from QA, QC, Engineering, and Operations.
• Prepare periodic health summaries highlighting risk signals and overdue actions.
• Assist with inspection-readiness activities related to CCS and governance triggers.
• Develop and revise program tools such as charters, templates, and dashboards.
• Coordinate deliverables across cross-functional stakeholders with clear documentation.

Skills

Senior contributor

Cross-functional coordination

GMP documentation

Risk-based thinking

Education

Bachelor's degree in microbiology/biotech/engineering

Tools

FMEA

Risk registers

Job description

Planet Pharma in Berkeley seeks a Sterility Assurance Principal Specialist to provide senior, individual contributor support across the Contamination Control program. You will translate strategy into practical deliverables, governance materials, risk docs, and action plans with Quality, QC Microbiology, Manufacturing, Engineering, Validation, Facilities, MSAT, and QRM.

This role emphasizes governance, risk documentation, inspection readiness, and metrics development without people management