Sterility Assurance Scientist - (Mansfield, MA)

Overview Responsibilities Maintains procedures and methodologies to cover sterilization programs Gains and applies knowledge of FDA, ISO and EN sterilization and related microbiology standards and guidelines to all tasks Supports technical assessments of contract sterilizers and laboratories Ensures adequacy of contamination control measures at external suppliers Provides training to procedural changes Provides input on the resolution of sterility related non-conformances Supports sterilization validations, cleaning validations, and supporting activities for all product families. Works with product development to ensure timely and complete sterilization adoptions and validations of all new products. Trains Product Development personnel in contamination control and sterilization requirements and procedures. Collaborates with Subject Matter Experts from other departments (i.e. Design Quality Engineering) to ensure a comprehensive approach to bring new and changed product into production.