Staff Microbiologist

Employer
Stryker
Location
Bloomington, Minnesota, US
Salary
Competitive
Posted
May 05, 2021
Closes
May 14, 2021
Ref
2137737087
Discipline
Genetics
Employment Type
Full time
Salary Type
Salary
About Stryker
Stryker is one of the world's leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World's Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com
Who we want:
Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes - finding ways to simplify, standardize and automate.
Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.
Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
Stryker is hiring a Staff Microbiologist in Bloomington, MN.
What you will do:
- Maintain sterilization programs for Ethylene Oxide, Gamma Irradiation and EBeam Irradiation.
- Work with test laboratories for perform bioburden and sterility testing as required per the sterilization monitoring program.
- Assess manufacturing process changes for potential impact to bioburden and endotoxin levels on sterile product.
- Maintain and review data routinely to show that the manufacturing processes are in a state of control.
- Perform endotoxin testing as required
- Write protocols and reports for microbiology related testing needs.
- Ensure accurate, reproducible, and timely QC testing in support of manufacturing; support development and validation studies on an as-needed basis
- Perform testing on in-process product, final product, and raw materials for routine testing and validation testing; communicate results through appropriate documentation and batch records, statistical analysis and trending; acquire and maintain cleanroom and gowning qualification; perform instrument maintenance; identify and report equipment and method failures; identify areas for continuous improvement
- Performs all aspects of the monitoring program with a working knowledge of company specifications and government regulations that govern the program
- Ensures that all testing is performed according to appropriate standards
- Performs necessary testing and analyzes data
- Reports findings in a clear and concise manner conforming to company format
- Trends data to ensure continued compliance
- Provides support to the manufacturing operation in areas related to quality from a microbiological standpoint.
- Reviews data and assigns disposition to several testing procedures including but not limited to sterility, bioburden, environmental data, validations, etc.
- Advise on microorganisms as they relate to the cleaning, disinfection and sterilization of reusable medical devices
- Advise on microorganisms as they relate to the terminal sterilization of single use medical devices
- Work closely with R&D teams to develop new products and lead continuous quality improvement initiatives
- Apply ISO, FDA and other applicable guidelines to the biological analysis of medical devices
- Actively support and advise on new product development activities with minimal support
- Lead and participate in the development and improvement of processes for existing and new products with minimal support
- Support the development, review and approval of sterilization process and equipment validation/qualifications (IQ, OQ & PQ) for terminally sterilized products
- Review nonconforming material and system documentation
- Support and advise regulatory teams on the review and writing of 510(k) submissions
- Participate in internal regulatory audits (FDA, notified body) as needed
- Maintain and improve internal SOP's / Work Instructions with respects to newly evolving and changing standards and regulatory environment
What you will need:
Basic Qualifications:
- Bachelor's Degree in Microbiology or a related discipline (Genetics, Cell Biology, Biology, etc.)
- 4+ years of experience in microbiology laboratory testing, cleanroom monitoring, and/or sterilization process monitoring
Preferred Qualifications:
- Laboratory equipment maintenance and validation experience
- Experience in medical device, biologics and/or pharmaceutical industries
- Excellent verbal and written communication skills
Know someone at Stryker?
Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program. (https://careers.stryker.com/referrals/)

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