Sterilization Engineer II

Remote • Posted 30+ days ago • Updated 4 hours ago
Full Time
On-site
Fitment

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Job Details

Skills

  • Process Engineering
  • Project Implementation
  • Testing
  • Optimization
  • ISO 9000
  • Pharmaceutics
  • Medical Devices
  • Turnover
  • Documentation

Summary

Summary:
The Sterilization Engineer is responsible for intermediate activities related to Development Services product and process development, fabrication, and sterilization of materials as work order needs dictate. The ideal candidate should have 7+ years of relevant experience in sterilization engineering within pharmaceutical or medical device environments.

Roles & Responsibilities:
Turnover, controls, care, and custody from EPCM to client.
Signature authority on equipment turnover.
Following paper trail of turnover package from start to finish.
Support sterilization process development and validation activities.
Coordinate with cross-functional teams for project execution.
Greenfield/Brownfield project experience preferred.

Education & Experience:
EO Sterilization Validation (ISO 11135).
EO Residual Testing (ISO 10993-7).
EO Sterilization Cycle Optimization (ISO 11135).
Process Challenge Device Development (ISO 11135).
Radiation Sterilization (ISO 11137).
Pharma / Biopharma / Medical Device industry experience required.
Experience handling commissioning, qualification, validation, and turnover documentation.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91116760
  • Position Id: f4fcf6233801ecd6e57c4a8bc078674d
  • Posted 30+ days ago
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