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Staff Microbiologist

Employer
Stryker
Location
Portage, Michigan, US
Salary
Competitive
Closing date
Sep 9, 2021

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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
Stryker is hiring a Staff Microbiologist to join our team in Portage, MI, Mahwah, NJ, Flower Mound, TX or Salt Lake City, UT.
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.
- Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
- Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
What you will do:
The Staff Microbiologist will be primarily responsible for the sterility compliance of Stryker's product in accordance with relevant regulatory requirements and standards for medical devices. You will oversee and ensure sustained levels of sterility compliance through testing, monitoring and validation of cleaning and sterilization processes and associated utilities.
The Staff Microbiologist will work within the Quality Management Systems Team, under general supervision, with responsibility to ensure effective and efficient sterility practices with strategic finished good Suppliers, which includes, but not limited to the following:
- Oversight of environmental monitoring of cleanrooms in line with ISO 14644 standards, and monitoring of utilities including all grades of water, and where necessary, compressed air, bio-burden and endotoxin testing.
- Interpreting sampling and monitoring data, applying statistical and analysis techniques, to determine control and trending. Identifies and initiates when to take action.
- Leads NC and CAPA generation and resolution within the Microbiology group and across related business units. Strong competency in troubleshooting, correction of NC and root cause analysis.
- Act as technical lead for microbiology in cross functional groups including product and process issues, root causing, projects, initiatives and other business critical forums.
- Applying cGLP to all laboratory activities including stock control.
- Performing sampling for validations and re-qualifications as required.
- Review of validation files for compliance.
- Strong interactions, maintenance and support of sterility suppliers.
- Interact with Supplier quality team with respect to vendor sterility topics.
- Performs sterility release review, interpreting data and trends.
- Performs sterilization validations and re-qualifications in line with relevant BS EN ISO standards.
- Continually identifies opportunity for stabilization of trends, statistical control of processes to allow cost saving.
- Mentors and trains team and cross functional groups as required (induction, GMP etc.)
- Subject matter expert to internal & external regulatory requirements, (including but not limited to European RHQ, Division, Corporate, FDA, ISO, MDD, and individual country regulatory requirements)
- Subject matter expert to local procedures, contribute to the development, maintenance and improvements of the policies and procedures to align to best practices, benchmarking against industry leads and regulatory requirements.
- Coach, mentor and train other functions in area of sterility and monitoring.
- Support of, ensure compliance of new products to sites' sterility standards. Ensure successful integration of products into validated processes.
- Ensures biocompatible of components, materials and consumables used in the manufacture of Stryker product.
- Provides Technical Assessment for completion of Risk Assessment for SofHA in area of sterility and microbiology.
- Demonstrate technical supervisory capabilities and leads projects to completion
- Demonstrates knowledge of the business processes and products across multiples sites.
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:
- Sterilization certificate and/or training
- Lead Auditor training and/or certification
- 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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