Sterility Assurance Expert
About The Position
This is an opportunity to play a critical role in protecting patients by shaping and defending sterility assurance strategies for advanced aseptic manufacturing. As the Sterility Assurance Expert, you will provide hands‑on technical leadership across aseptic processing, microbial control, environmental monitoring, and contamination investigations, ensuring every decision is scientifically sound, data‑driven, and inspection‑ready. Partnering closely with Operations, Quality, and Technical teams, you will serve as a trusted authority who drives risk‑based decisions, strengthens compliance with evolving regulatory expectations, and continuously improves sterility assurance programs in a highly regulated, mission‑critical environment.
Requirements
- Bachelor’s degree in a scientific or technical field, preferably Microbiology or a related discipline
- Extensive experience supporting sterility assurance programs in regulated biopharmaceutical manufacturing environments
- Deep understanding of aseptic processing, microbial control strategies, and contamination risk management
- Proven experience leading sterility‑related investigations, environmental monitoring programs, and corrective action planning
- Strong knowledge of global regulatory expectations, including United States and European health authority requirements
- Ability to apply scientific judgment, analyze complex data, and communicate clear, compliant recommendations
Nice To Haves
- Experience supporting sterility assurance activities for aseptic cell or gene therapy manufacturing
- Direct participation in regulatory inspections with ownership of sterility assurance topics and responses
Responsibilities
- Serve as site sterility assurance expert for aseptic processing and microbial control programs
- Design, maintain, and improve sterility assurance strategies aligned with global regulatory expectations
- Lead sterility‑related deviations, contamination investigations, and risk‑based decision making
- Own environmental and personnel monitoring strategies, including trending, escalation, and continuous improvement
- Author, review, and approve sterility assurance documentation, validations, and technical rationales
- Represent sterility assurance during regulatory inspections, audits, and quality governance forums
- Partner cross‑functionally to resolve sterility risks and strengthen inspection readiness and compliance
Benefits
- performance‑based bonus
- full range of medical, financial, and other benefits
- retirement programs
- paid time off
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
