Project Microbiologist 100% F/m
Vor 2 Tagen
Founded in 1927 and headquartered in Warsaw, Indiana, USA, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; spine, bone healing, craniomaxillofacial and thoracic products; dental implants; and related surgical products.
We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.
For our Production in Winterthur (Switzerland), we are looking for a
**Project Microbiologist 100% f/m**:
**Job Summary**:
Responsible for project planning and routine surveillance, tracking and reporting at Zimmer Winterthur
with regards to sterilization, biological evaluation, environmental and utility controls. Collaborates in project work with the microbiological laboratory, and other departments like process engineering, manufacturing, quality and regulatory as well as with other sites and Zimmer. 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
- 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.)
- 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
**Zimmer Switzerland Manufacturing GmbH**
Human Resources
Sulzerallee 8
8404 Winterthur
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