Staff Microbiologist - Utah, Salt Lake City 4870 West 2100 South

Work Flexibility: Onsite

Stryker is hiring a Staff Microbiologist in Salt Lake City, Utah, to support Neurovascular! In this role, you 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. 

We're looking for someone to lead the setup of our microbiology lab, focusing on optimizing processes and enhance our capabilities!

Who we want:

• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.

• Collaborative Partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.

• Dedicated achievers. Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

What you will do:

Working within the microbiology team, you will ensure effective and efficient sterility practices, 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, bioburden and endotoxin testing.

• Interpreting sampling and monitoring data, applying statistical and analysis techniques, to determine control and trending.

• Leads NC and CAPA generation and resolution within the Microbiology group and across related business units.

• 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. 

• Interact with Supplier quality team with respect to vendor sterility topics. 

• Performs sterility release review, interpreting data and trends. Common methods include Ethylene Oxide Sterilization and Gamma Ray Sterilization.

• 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. 

• 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. 

• 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 in the area of sterility and microbiology. 

• Demonstrates knowledge of the business processes and products across multiples sites. 

• Mentors and trains team and cross functional groups as required.

What you need:

Required

• ​​Bachelor’s degree in Microbiology or a related discipline i.e., Biomedical Engineering, Biology, Genetics, Engineering, etc.

• 4+ years’ experience as a Microbiologist (Cleaning, Disinfection, Biocompatibility, or Sterilization) in a regulated industry.

Preferred

• Demonstrate technical supervisor capabilities and leads projects to completion. 

• Strong competency in troubleshooting, correction of NC and root cause analysis. 

Travel Percentage: 20%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.