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Sterilization Engineer/Scientist

gomillenniumsoft.com Logo

MillenniumSoft Inc

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Location:
United States , Andover

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Category:

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Contract Type:
Not provided

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Salary:

60.00 - 65.00 USD / Hour

Job Description:

Lead efforts to develop sterilization cycle and methodologies for new product development. This position will also be accountable in managing Andover cleanroom/s.

Job Responsibility:

  • Lead sterilization cycle definition, development, and validation
  • Work with cross functional team as subject matter expert
  • Manage and coordinate routine sterilization including test related to release of the lots
  • Creation and maintenance of standard operating procedure and work instruction
  • Manage and maintain the Andover Environmental Monitoring program
  • Cleanroom training and qualification of embecta associates
  • Coordinate and schedule the environmental monitoring and cleaning of the Andover cleanroom
  • Investigate and resolve EM excursions
  • Create/prepare Environmental Monitoring monthly metrics

Requirements:

  • Ethylene Oxide sterilization and validation experience
  • Microbiology experience
  • Environmental monitoring experience
  • BS degree in engineering, science, or technical discipline
  • Minimum of 3-5 years relevant technical experience in EtO sterilization
  • Medical Device industry experience preferred
  • Extensive knowledge in ISO 10993, ISO 11135, ISO 14161, ISO 11737, ISO 10993, ISO 14698 and ISO 14644
  • Excellent verbal and written communication skills

Nice to have:

  • MS degree preferred
  • Medical Device industry experience preferred

Additional Information:

Job Posted:
January 11, 2026

Employment Type:
Fulltime
Work Type:
On-site work
Job Link Share:

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