Sterility Assurance Expert

Location: Morris Plains, NJ, United States. Relocation support is not available for this role.

About The Role

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. You will partner closely with Operations, Quality, and Technical teams, serving 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.

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

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) within a commercial GMP manufacturing facility, including defense of sterility assurance, aseptic processing, or microbial control programs
• Minimum of five years direct experience supporting commercial aseptic manufacturing operations within a cGMP-regulated environment, including routine production support, deviation management, change control, and real-time risk assessment
• 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

Qualifications

• Experience supporting sterility assurance activities for aseptic cell or gene therapy manufacturing is a plus

Pay

The pay range for this position at commencement of employment is expected to be between $108,500 and $201,500 per year. Final pay determinations will depend on geographic location, experience level, knowledge, skills, and abilities. The total compensation package may also include a performance-based bonus and a full range of medical, financial, and other benefits, including retirement programs and paid time off.

Benefits

Learn about all the ways we’ll help you thrive personally and professionally, including medical, financial, and retirement benefits, as well as paid time off. More details about our culture, rewards, and benefits.