Sterility Assurance Principal Specialist

The Sterility Assurance Principal Specialist provides senior individual contributor support for the Sterility Assurance and Contamination Control Program. This advanced quality professional role focuses on program governance, metrics, risk documentation, action tracking, and inspection readiness. Collaboration spans Quality, QC Microbiology, Manufacturing, Engineering, Validation, Facilities, MSAT/Technical Operations, and QRM teams to translate the Contamination Control Strategy into practical deliverables and risk‑based improvements.

What You’ll Do

• Implement sterility assurance program – Support execution and governance of contamination control and sterility assurance initiatives.
• Maintain trackers & metrics – Oversee CCS action tracker, risk rankings, progress updates, and escalation needs.
• Prepare leadership updates – Develop council agendas, decision records, risk summaries, and inspection‑readiness reports.
• Partner with QRM – Document, prioritize, and escalate contamination control risks.
• Develop site metrics – Use QA, QC Microbiology, Engineering, and Operations data to build sterility assurance dashboards.
• Support inspection readiness – Track high‑risk gaps, CAPA effectiveness, contamination patterns, and audit preparedness.
• Create governance tools – Draft charters, templates, decision trees, dashboards, and communication materials.

What We Need

• Experience – 8+ years in pharma, biotech, biologics, sterile manufacturing, cell therapy, or aseptic processing.
• GMP expertise – Strong knowledge of deviations, CAPA, change control, risk management, and inspection readiness.
• Contamination control knowledge – Proven background in sterility assurance principles.
• Cross‑functional collaboration – Experience working with Quality, QC Microbiology, Manufacturing, Engineering, Validation, Facilities, MSAT, or Technical Operations.
• Risk assessment skills – Familiarity with FMEA, HACCP, fault tree analysis, and risk registers.
• Technical writing – Strong documentation, facilitation, and communication skills.
• Preferred background – Experience in contamination control strategy, aseptic manufacturing, environmental monitoring, APS/media fills, cleaning/disinfection, microbial investigations, and regulatory inspections.

Education & Training

• Bachelor’s degree in Microbiology, Biology, Biotechnology, Engineering, Pharmaceutical Sciences, or related field.
• Familiarity with EU GMP Annex 1, FDA aseptic processing guidance, ICH Q9/Q10, PDA technical reports, ISO cleanroom standards.

Additional Details

• Start Time: 9:00 AM
• Contract Duration: 12–18 months, with potential extension
• Senior individual contributor role (no direct people management)

HarveStaff LLC is an Equal Opportunity Employer.

JOB-10047624