The Senior Sterility Assurance Specialist works independently to plan and execute sterility activities to support new/modified products and processes in accordance with applicable regulations, standards and guidelines. S/he will serve as a subject matter expert on current medical device terminal sterilization technologies (i.e. EO, Radiation), controlled environments, and related microbiological testing.
Job Details: • Supports New Product Development and Operations Engineering teams creating and implementing plans for sterility assurance activities to support new/modified products/processes • May lead the development/modification of sterilization processes for new or existing products • Develop, review and approve sterilization process qualifications and routine dose audits. • Develop, qualify and implement microbiological test methods to support sterility assurance of products • Review sterilization and laboratory documentation to ensure compliance with procedures • Apply cGLP, cGMP, AAMI, ISO, FDA USP guidelines to microbiological development validation such as bioburden, bacterial endotoxin, growth promotion • Support cleanroom and installation and qualification activities including protocol development, review and/or approval. • Lead investigations to resolve sterilizer non-conformance reports, including corrective/ preventative, by applying knowledge of industry standards • Serve as subject matter expert & participate in regulatory agency interactions during audits • Lead or participate in auditing contract labs and sterilizers • Keep abreast of current technologies and regulatory standards. • Performs other job-related duties assigned
o Bachelor degree in Biology, Microbiology, or related science.
o Minimum of 7 years of experience with sterilization process in medical device industry 5 years of which are in ethylene oxide sterilization validation
Knowledge, Skills and Abilities (KSAs)
o Demonstrated experience in development and modification of sterilization processes
o Significant knowledge of EO sterilization requirements of ISO 11135 and gamma sterilization ISO 11137 is required. With knowledge in other sterilization techniques such as dry or moist heat desirable.
o Demonstrated experience in a variety of microbiological methods (bioburden, bacterial endotoxin, microbial isolation and characterization)
o Demonstrated strong analytical and problem-solving skills; ability to solve complex problems and implement solutions or processes
o Working knowledge of Good Laboratory and Good Manufacturing practices.
o Knowledge of product particulate testing a plus.
o Experience in establishing/maintaining working relationships with contract laboratories
o Excellent communication skills, verbal and written, and interpersonal skills. Ability to interact with internal and external contacts at all levels.
o Ability to work independently, set priorities and handle multiple tasks with high level of efficiency
o Working knowledge of Microsoft office applications including Word, Excel, PowerPoint, Outlook and MS Project
Terumo is an Equal Opportunity Employer