Maryland Green Jobs

Maryland Mobile Logo

Job Information

Terumo Medical Corporation Sr. Sterility Assurance Specialist in Elkton, Maryland

Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world’s leading medical device manufacturers with $5+ billion in sales, 20,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products.

Job Summary:

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

Knowledge, Skills, Abilities

  • Demonstrated experience in development and modification of sterilization processes

  • 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.

  • Demonstrated experience in a variety of microbiological methods (bioburden, bacterial endotoxin, microbial isolation, and characterization)

  • Demonstrated strong analytical and problem-solving skills; ability to solve complex problems and implement solutions or processes

  • Working knowledge of Good Laboratory and Good Manufacturing practices.

  • Knowledge of product particulate testing a plus.

  • Experience in establishing/maintaining working relationships with contract laboratories

  • Excellent communication skills, verbal and written, and interpersonal skills. Ability to interact with internal and external contacts at all levels.

  • Ability to work independently, set priorities and handle multiple tasks with high level of efficiency

  • Working knowledge of Microsoft office applications including Word, Excel, PowerPoint, Outlook, and MS Project.

Background, Experiences

  • Bachelor’s degree in biology, Microbiology, or related science.

  • Minimum of 7 years of experience with sterilization process in medical device industry of which 5 years of experience in ethylene oxide sterilization validation

It is Terumo’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.

Job Category: Sterilization

Affirmative Action/Equal Employment Opportunity Statement

It is the Company's policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment. In compliance with the Americans with Disabilities Act (ADA), if you have a disability and would like to request an accommodation with regard to the application and selection processes (for example, the online application process or interviews) or have any questions about our website accessibility, please call 732-302-4902 or e-mail us at Staffing@Terumomedical.com.

DirectEmployers