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Sterilization and Contamination Control Engineer
Sterilization and Contamination Control Engineer
As one of the world´s leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce. The work of our committed, highly specialized, exceptionally skilled employees results in crucial advancements in the world of cardiology and changes the lives of patients every day.
The Sterilization and Contamination Control department in Bülach, Zürich delivers the application and practice of microbial assurance as applied to the design, manufacture, and sterilization of implants while ensuring that the company meets all applicable standards and regulations requirements.
Your Responsibilities
- To support the validation of sterilization processes using Ethylene Oxide, Irradiation and Moist Heat
- To support the qualification and contamination control of medical devices in ISO Classified cleanrooms
- Test method development for bioburden, endotoxin, sterility testing and equipment qualifications within the laboratory
- To support New Product Development teams in the design of products with cleaning and sterilization in mind
- Perform failure, NC and CAPA investigations and implement required actions
Your Profil e
- Degree level qualification in Medical/Mechanical Engineering, Biomedical Sciences, Microbiology or similar
- Minimum 2 years post qualification experience in sterilization and contamination control in a medical device, pharmaceutical, or similar regulated industry
- Knowledge of the following ISO Standards: 11135, 11137, 14160, 11737, 14644, 14648, 10993
- Fluent in German is an advantage but not essential
Are you interested?
Please apply online via our application management system. We are looking forward to welcoming you!
Location: Bülach, Zürich | Working hours: Vollzeit | Type of contract: Unbefristet
Apply now: www.biotronik.com/careers | Job ID: 37061
- Only direct applications via our application management system will be considered -
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.