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Tech Transfer Process Engineer

Job in Seattle, King County, Washington, 98127, USA
Listing for: United Pharma
Full Time position
Listed on 2026-09-23
Job specializations:
  • Manufacturing / Production
    Validation Engineer, Pharmaceutical Manufacturing, Quality Engineering
  • Engineering
    Validation Engineer, Quality Engineering, Pharma Engineer
Salary/Wage Range or Industry Benchmark: 120000 - 160000 USD Yearly USD 120000.00 160000.00 YEAR
Job Description & How to Apply Below

The Process Engineer will support the transfer of new products into a CDMO manufacturing site, working closely with clients and cross-functional teams to ensure successful process transfer, development, and validation.

This is a hands-on manufacturing-floor role focused primarily on incoming NPI technical transfers, process development, risk assessment, batch execution, and technical documentation.

Key Responsibilities:
  • Lead and support NPI technical transfer activities for sterile/aseptic fill-finish products.
  • Collaborate directly with clients to gather and evaluate product, process, and technical data
    .
  • Develop and author Technical Transfer Plans, Process Control Strategies, and transfer documentation
    .
  • Coordinate activities required to develop, establish, and validate processes at the manufacturing site.
  • Perform process risk assessments and identify potential manufacturing risks and mitigation strategies.
  • Develop and execute hands-on batch sampling and process study protocols
    .
  • Provide on-floor engineering support during manufacturing runs, process trials, and technical transfer activities
    .
  • Support change controls, deviations, investigations, and corrective actions associated with transferred products.
  • Ensure activities are completed in accordance with GMP, site procedures, and applicable pharmaceutical regulations
    .
Required

Skills & Experience:
  • 8-10+ years of pharmaceutical industry experience
    .
  • Strong CDMO experience in a fast-paced manufacturing environment.
  • Hands-on experience with sterile/aseptic fill-finish manufacturing
    .
  • Experience working directly on or supporting commercial/manufacturing lines
    .
  • Proven experience with NPI and technical transfer activities
    .
  • Strong understanding of process development, process validation, and manufacturing readiness
    .
  • Experience with risk assessments, protocols, change controls, deviations, and technical reports
    .
  • Comfortable working directly with clients and cross-functional teams.
  • Must be hand-on and willing to work on the manufacturing floor
    .
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