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Director, Microbiology and Sterility Assurance

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Company :
3M Health Information Systems

Location :
Maplewood, Minnesota

Expiry Date :
Tue, 15 Jun 2021 23:59:59 GMT

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Description :
Job Description: Director, Microbiology and Sterility Assurance Collaborate with Innovative 3Mers Around the World Choosing where to start and grow your career has a major impact on your professional and personal life, so its equally important you know that the company that you choose to work at, and its leaders, will support and guide you. With a diversity of people, global locations, technologies and products, 3M is a place where you can collaborate with 96,000 other curious, creative 3Mers. 3Ms culture is driven by curious, spirited and collaborative people who are constantly asking What if? And the many talents of 3Mers around the globe have me incredibly excited about whats to come next. Kristen Ludgate, executive vice president and chief Human Resources officer at 3M This position provides an opportunity to transition from other private, public, government or military environments to a 3M career. The Impact Youll Make in this Role As a Director, Microbiology and Sterility Assurance you will lead global microbiology and sterility assurance activities and deliverables for both marketed products and new product development projects within the Medical Solutions Division (MSD). You will also have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by: – Interpreting industry trends, customer requirements, and business objectives to define divisional guidelines and methods for microbiology and sterilization disciplines for all divisional products and sites globally – Defining Sterility Assurance strategy for New Product Introduction (NPI) projects, and manages allocation of sterility assurance resources – Maintaining a strong operational knowledge of industry sterilization technologies, including gamma, Ethylene Oxide (EO), steam, x-ray, and emerging modalities – Collaborating with other functions on sterilization deliverables for regulatory submissions (sterilization validation/requalification protocols and reports) for EO and Gamma sterilization per International Organization for Standardization (ISO) 11135 and 11137 sterilization standards – Providing sterility assurance support during compliance and regulatory audits and inspections – Supporting ongoing manufacturing including environmental monitoring, product release, EO re-qualifications, quarterly dose audits, and product changes related to microbiology and sterilization – Coordinating sterilization testing (bioburden, sterility, EO residuals, etc.) related to sterilization activities with contract testing laboratories according to applicable standards (ISO 11737, ISO 10993-7, etc.) and interpret/document results – Initiating and approving projects to continuously improve efficiency and competitiveness, and determines priorities, timetables, and assigns resources/tasks – Ensuring thorough and timely investigations and root cause analysis related to sterilization issues – Performing microbiological evaluations of product and processes Your Skills and Expertise To set you up for success in this role from day one, 3M requires (at a minimum) the following qualifications: – Bachelor’s degree in a science discipline (completed and verified prior to start) from an accredited institution – Seven (7) years of leadership/management experience working in a sterility assurance and/or microbiology function (private, public, government or military) Additional qualifications that could help you succeed even further in this role include: – Bachelors degree or higher in Microbiology from an accredited institution – Seven (7) years of experience working in the medical device industry – Strong knowledge of Good Manufacturing Practice (cGMP) and experience working in a Food and Drug Administration (FDA) regulated environment – Working knowledge of ISO sterilization standards for EO (ISO 11135), Gamma (ISO 11137) and Dry Heat (ISO 20857) – Experience working with microbiological sterility testing and/or bioburden test methodologies Travel: May include up to 20% domestic/international Relocation Assistance: May be authorized Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status). Supporting Your Well-being 3M offers many programs to help you live your best life both physically and financially. To ensure competitive pay and benefits, 3M regularly benchmarks with other companies that are comparable in size and scope. Resources for You For more details on what happens before, during and after the interview process, check out the Insights for Candidates page at Learn more about 3Ms creative solutions to the worlds problems at or on Twitter @3M. Responsibilities of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties. 3M is an equal opportunity employer. 3M will not discriminate against any applicant for employment on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status. Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly. 3M Global Terms of Use and Privacy Statement Carefully read these Terms of Use before using this website. Your access to and use of this website and application for a job at 3M are conditioned on your acceptance and compliance with these terms. Please access the linked document by clicking here, select the country where you are applying for employment, and review. Before submitting your application you will be asked to confirm your agreement with the terms.