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Staff Scientist, Microbiological Quality & Sterility Assurance

Johnson & Johnson · Groningen, Netherlands

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Role summary

Staff Scientist role supporting microbiological quality and sterility assurance strategies across Johnson & Johnson Vision's global operations. Responsibilities span new product introductions, process validations, sterilization site management, regulatory compliance, and contamination control initiatives.

What they're looking for

  • Expert knowledge of microbiological quality, sterility assurance, and aseptic processing
  • Experience with sterilization validation, process characterization, and terminal sterilization methods
  • Regulatory affairs familiarity and ability to support FDA/global submissions
  • Strong technical expertise in cleanroom operations and contamination control strategies
  • Site audit and quality agreement review experience
  • Ability to lead cross-functional teams and collaborate with R&D and manufacturing

What you'll be doing

  • Lead new product introductions as core team member, including protocol development and regulatory liaison
  • Conduct on-site validations and audits at contract sterilization and manufacturing sites globally
  • Drive sterility assurance strategy and process improvements across product portfolio and manufacturing operations
  • Support selection and qualification of external manufacturers, contract labs, and sterilization vendors
  • Provide technical expertise for test method validations, change controls, and regulatory audit readiness

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Date posted1 day ago
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