Job Description
Corporate (list is not exhaustive).
General Functions:
- Coordination, review and approval of product sterilization validations, such as gamma sterilization. Dose map review and approval, ETO sterilization validation and routine monitoring
- Development of separate sterilization validation groups to mitigate risk of dose audit failures
- ETO and gamma sterilization certificates release
- Internal technical document creation and approval
- Participate in internal and external audits as subject matter expert
- Create Technical Reviews, specifications and other mandatory documents regarding sterilization and biological evaluation for regulatory submissions
- Resource for sterilization and cleaning issues for new product development
- Order and tracking of microbiology lab analyses like ID (genus and species) for environmental, bioburden and dose audit organisms, bacterial endotoxin testing, bioburden testing and dose audit testing
- Biocompatibility assessment and organization of respective testing
- Cleanroom IQ/OQ/PQ validations and resource for clean room design, validation and troubleshooting
Education / Experience Requirements:
- Minimum educational requirement is a BSc. degree in relevant scientific disciplines, such as microbiology and molecular biology (preferred is a MS degree)
- An advanced degree or significant experience in the field of medical device sterilization and industrial microbiology is preferred
- Solving a variety of complex sterilization, microbiological and contamination control issues
- Testing or experiments required and judging which tests are/are not critical in order to proceed
- with the project
- Good knowledge of industry standards (ANSI, AAMI, ISO, PDA, etc.)
- Serves as a specialist and consultant in the application of sterilization and micro-biological principles, work processes,
- Fluent in German and English, also written
- Strong problem solving skills. Able to analyze all aspects of a situation, identify potential solutions, and implement the best solution in a timely manner
If you seize this opportunity, you will be able to develop your international experience and be a part of a great and truly global team. Zimmer Biomet offers a wide range of challenging career advancement opportunities and a dynamic work environment. We look forward to receiving your complete application online through the Zimmer Biomet Homepage.
Job ID: 114657