Sterility Assurance Expert

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

Essential Requirements:
- Bachelor’s degree in a scientific or related technical field
- Extensive experience supporting sterility assurance programs in regulated biopharmaceutical manufacturing environments
- Demonstrated participation in regulatory health authority inspections (e.g., FDA, EMA, MHRA, TGA) in a commercial GMP facility, including defense of sterility assurance, aseptic processing, or microbial control programs
- Minimum 5 years direct experience supporting commercial aseptic manufacturing operations in a cGMP-regulated environment (routine production support, deviation management, change control, real-time risk assessment)
- Proven experience leading sterility-related investigations, environmental monitoring programs, and corrective action planning
- Strong knowledge of global regulatory expectations (US and European health authority requirements)
- Ability to apply scientific judgment, analyze complex data, and communicate clear, compliant recommendations

Desirable:
- Experience supporting sterility assurance activities for aseptic cell or gene therapy manufacturing (plus)