Sr. Sterility Assurance Scientist

Senior Sterility Assurance Scientist role supporting regulatory compliance and sterilization programs across manufacturing sites. The position requires expertise in medical device sterilization standards, contamination control, and microbiology to ensure FDA, ISO, and international regulatory adherence.

Responsibilities

• Serve as subject matter expert for sterilization programs and standards across company sites
• Maintain, revise, and develop sterilization procedures ensuring regulatory compliance with FDA, ISO, and EU MDR requirements
• Conduct gap analysis for EU MDR compliance and formulate resolution strategies
• Support sterilization, cleaning, and bioburden validations for all product families and new processes
• Evaluate contract sterilizers and monitor contamination control measures at external suppliers

Requirements

• Bachelor's degree in Microbiology, Biological Sciences, or Engineering
• 10+ years of experience with sterilization in medical devices or pharmaceuticals
• Working knowledge of ISO 11135, ISO 11137, and sterilization regulatory standards
• Proficiency in Microsoft Office and sterilization-related software
• Strong written and oral communication skills for cross-functional collaboration
• Experience writing standard operating procedures, protocols, and validation reports
• Ability to travel 25% domestically and internationally

Compensation: $81,650-$112,700 USD base salary