Sr Sterility Assurance Scientist

Role: The Sterility Assurance Scientist ensures compliance with global sterilization and contamination control standards (FDA, ISO 13485, EU MDR) across manufacturing sites. Responsibilities include maintaining and revising sterilization procedures, supporting validations, assessing contract sterilizers, and providing contamination control training. They collaborate closely with Product Development, Regulatory, Quality, and Operations to ensure sterilization processes, including novel methods, meet regulatory and technical standards. The role involves performing gap analyses for EU MDR compliance, supporting sterilization-related investigations, and participating in audits. Qualifications: Bachelor's degree in Microbiology, Biological Sciences, or Engineering; 10+ years of experience in sterilization/microbiology within medical device, pharmaceutical, or food industries; knowledge of ISO sterilization standards (ISO 11135/11137), and regulatory guidelines. Skills include strong collaboration, documentation, critical thinking, and regulatory compliance expertise. High-Value: Focus on contamination control, sterilization validation, regulatory adherence (FDA, EU MDR), and microbiological standards. Work setup involves cross-functional teamwork in a regulated manufacturing environment, with travel up to 25% domestically and internationally.