Sr. Sterility Assurance Scientist

Role: Sterility Assurance Scientist supporting sterilization compliance and contamination control in medical device manufacturing. Responsibilities include developing and revising sterilization procedures, ensuring adherence to FDA, ISO 13485, EU MDR, and other microbiological standards, and supporting sterilization and cleaning validation activities. The role involves assessing contract sterilizers, monitoring contamination control measures at external sites, providing training, and contributing to regulatory compliance efforts, including gap analysis for EU MDR. Requirements: Bachelor's degree in Microbiology, Biological Sciences, or Engineering; 10+ years of experience in sterilization/microbiology within medical device, pharmaceutical, or food industries; working knowledge of ISO sterilization standards (ISO 11135, 11137); familiarity with regulatory guidelines and microbiological control. Preferred: Experience with SOP writing, protocol development, and cross-functional collaboration. High-value specifics include expertise in sterilization validation, contamination control, microbiology, and regulatory compliance related to sterile medical devices. The candidate must demonstrate strong communication, organizational, and analytical skills, with ability to work under pressure and travel up to 25%. The position is focused on ensuring sterilization processes meet global standards and supports product development and manufacturing in a regulated environment.