Who we want
Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
Goal-oriented developers . Keeping the customer and system requirements squarely in focus, people who deliver safe and robust solutions.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
What you will do
As a Microbiologist, you will coordinate microbiological and/or chemical testing, release of product and testing for validation protocols. You will perform organism identification and technical reviews of batch filling records to ensure quality of aseptic processes. This person will also be responsible for reading and interpreting microbiological cultures and other related tests including but not limited to environmental monitoring, sterility tests, growth promotion, microbial limits tests and antimicrobial effectiveness tests. In this role you may perform validation, technology transfer and troubleshooting, and write policy procedure for quality initiatives. This person will also be responsible for reviewing and approving environmental monitoring data and laboratory equipment and records. You will also prepare process and status reports, assign and monitor document numbers and review documents for accuracy and completeness.
Identify, isolate and study microorganisms and their byproducts as it relates to the manufacturing and sterilization of medical devices. Practices the following sterilization techniques: gamma irradiation, ethylene oxide or moist heat. Review biocompatibility tests and interpret the associated industry guidelines. Work with operations and research groups to support continuous quality improvement initiatives.
Apply cGLP, cGMP, ANSI, AAMI, ISO, FDA, EPA, and USP guidelines to the bioburden, cytotoxicity, bacterial endotoxin/LAL, and biocompatibility analysis of orthopaedic implants and surgical instruments.
Participate in the development and improvement of the manufacturing processes for existing products.
May lead in the development, review and approval of sterilization process and equipment validation/qualifications (IQ, OQ & PQ).
Be the point of contact for suppliers for process changes, quality issues and process improvements for assigned projects.
Support product transfers to other plants/facilities.
Review/approve nonconforming material and system documentation.
Review/approve product and process change control documentation and specifications.
Act as mentor to others.
What you need
Minimum 2 years’ experience in applied device or pharmaceutical microbiological or biological testing, research and development, or sterility assurance experience.
Bachelor’s Degree in Biology, Microbiology, or a closely related life science field.
Understanding the fundamentals of two of the following sterilization techniques: gamma irradiation, ethylene oxide or, moist heat.
Demonstrated experience with biocompatibility tests, ability to interpret the associated industry guidelines.
Demonstrated competency in advanced testing technologies.
Knowledge about a variety of microbiological concepts, practices, and procedures.
Ability to use ISO, AAMI, USP, ANSI, EPA, EU and related guidelines toward the design and manufacturing of initiatives.
Ability to effectively work cross-functionally with Product Development, Planning, Purchasing, Operations, Quality Assurance and Marketing.
Demonstrated communication skills across different organizational levels.
Work From Home: No
Travel Percentage: Up to 25%
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.