Senior Sterility Assurance Principal Specialist

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

Job summary

Planet Pharma in Berkeley is seeking a Sterility Assurance Principal Specialist to provide senior individual contributor support for the site’s Sterility Assurance and Contamination Control program. This contract role covers program structure, governance, metrics, action tracking, risk documentation, and inspection-readiness.

You will partner with Quality, QC Microbiology, Manufacturing, Engineering, Validation, Facilities, MSAT, and QRM to translate strategy into practical deliverables, action

Qualifications

• Bachelor’s degree in microbiology, biology, biotechnology, engineering, pharmaceutical sciences, or a related scientific/technical field.
• Minimum 8 years of experience in pharmaceutical, biotechnology, biologics, sterile manufacturing, cell therapy, or aseptic processing environments.
• Experience supporting contamination control, sterility assurance, quality systems, validation, QC Microbiology, manufacturing technical support, or GMP program execution.
• Strong GMP knowledge, deviations, CAPA, change control, risk management, documentation, and inspection readiness.

Responsibilities

• Support continued implementation of the Berkeley Site Sterility Assurance and Contamination Control Program, including program roadmap, workstream tracking, governance materials, and execution follow-up.
• Maintain the site CCS / sterility assurance action tracker, including assigned owners, due dates, dependencies, risk ranking, progress updates, and escalation needs.
• Support preparation of Sterility Assurance Council materials, including agendas, action logs, decision records, risk summaries, and leadership updates.
• Partner with the QRM program/SME to ensure contamination control risks are documented, prioritized, escalated, and reviewed using approved site risk-management processes.
• Support development of site-level sterility assurance metrics by integrating existing source data from QA, QC Microbiology, Engineering, Manufacturing, Validation, and Operations without duplicating functional dashboards.
• Prepare periodic Sterility Assurance / Contamination Control health summaries highlighting key risk signals, open high-risk gaps, overdue actions, repeat contamination patterns, CAPA effectiveness, and inspection-readiness status.
• Assist with inspection-readiness activities related to CCS, contamination control governance, QRM linkage, risk-based decisions, CAPA tracking, and sterility assurance program maturity.
• Support development and revision of program-level tools such as charters, templates, decision trees, governance triggers, risk review forms, dashboards, and communication materials.
• Coordinate assigned deliverables across cross-functional stakeholders while maintaining clear documentation, follow-up, and escalation of risks or overdue items.

Skills

Strong technical writing

Organization

Facilitation

Communication skills

Education

Bachelor's degree in microbiology/biotechnology/engineering

Job description

Planet Pharma in Berkeley is seeking a Sterility Assurance Principal Specialist to provide senior individual contributor support for the site’s Sterility Assurance and Contamination Control program. This contract role covers program structure, governance, metrics, action tracking, risk documentation, and inspection-readiness.

You will partner with Quality, QC Microbiology, Manufacturing, Engineering, Validation, Facilities, MSAT, and QRM to translate strategy into practical deliverables, action