3M Sterility Assurance Specialist Recruitment – Apply Online

3M Sterility Assurance Specialist Recruitment – Apply Online

Choosing where to start and grow your career has a major impact on your professional and personal life, so it’s 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.

Job Title: Sterility Assurance Specialist (Remote, Proximate to any major U.S. Airport)

Location: US, Minnesota, Maplewood

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 or higher (completed and verified prior to start) from an accredited institution
  • Five (5) years of combined experience working in a Sterility Assurance, Quality, Engineering, Microbiology and/or Laboratory/technical function in a private, public, government or military environment

Additional qualifications that could help you succeed even further in this role include:

  • Master’s degree or higher in Microbiology or Biology discipline from an accredited institution
  • Seven (7)years of combined experience working in a Sterility Assurance, Quality, Engineering, Microbiology and/or Laboratory/technical function in a private, public, government or military environment
  • Experience with ISO sterilization standards for EO (ISO 11135), Gamma (ISO 11137) and/or Moist Heat (ISO 17665)
  • Experience with Good Manufacturing Practice (cGMP) and experience working in an FDA regulated environment
  • Experience with project management and integrating new systems

The Impact You’ll Make in this Role

As a Sterility Assurance Specialist, you will 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:

  • Leading international sterility assurance integration activities for a recent acquisition and managing a complex product portfolio at internal and external manufacturing sites
  • Collaborating cross-functionally with R&D, regulatory affairs, quality, and internal and external manufacturers to ensure compliance to International Organization for
  • Standardization (ISO) and Food and Drug Administration (FDA) requirements for terminally sterilized healthcare products
  • Performing sterility assurance activities and deliverables for both marketed products and new product development projects globally per international and the U.S, standards such as ISO 11135, ISO 11137, ISO 17665, and others as applicable
  • Supporting ongoing manufacturing including environmental monitoring, Ethylene Oxide (EO) requalification, quarterly dose audits, and product/process changes related to sterilization
  • Providing sterility assurance support during compliance, regulatory, and supplier audits
  • Ensuring thorough and timely investigations and root cause analysis related to sterility assurance issues
  • Applying working knowledge of ISO standards, sterility assurance, and microbiology principles to assigned processes and products

3M Sterility Assurance Specialist

Apply Online

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