Senior Process Engineer

IT MINDS L.L.C.

  • Spokane, WA
  • 2 days ago

    Highlights

    Job Title: Senior Process Engineer Fill/Finish Technology Transfer Location: Spokane Washington Duration: Contract Job Description: We are seeking a highly experienced Senior Process Engineer to lead a large-scale Fill/Finish Technology Transfer project within a pharmaceutical manufacturing environment. The ideal candidate will have extensive experience in sterile drug product manufacturing, process validation, and technology transfer, with the ability to independently lead cross-functional teams and drive project execution from planning through commercialization.

    Numbers & Facts

    LocationSpokane, WA

    Description

    Job Title:Senior Process Engineer Fill/Finish Technology TransferLocation:Spokane WashingtonDuration:ContractJob Description: We are seeking a highly experienced Senior Process Engineer to lead a large-scale Fill/Finish Technology Transfer project within a pharmaceutical manufacturing environment. The ideal candidate will have extensive experience in sterile drug product manufacturing, process validation, and technology transfer, with the ability to independently lead cross-functional teams and drive project execution from planning through commercialization. Responsibilities
    • Lead end-to-end Fill/Finish technology transfer activities.
    • Review and assess process documentation, batch records, and technology transfer packages.
    • Identify documentation and process gaps and drive timely resolution.
    • Develop and implement process control strategies supporting validation and commercial manufacturing.
    • Lead engineering, PPQ, validation, and commercial batch execution.
    • Develop and own the process validation strategy.
    • Provide technical leadership and guidance for validation protocols and reports.
    • Collaborate with Manufacturing, Engineering, Quality, Validation, and external clients.
    • Serve as the technical lead for successful technology transfer execution.
    Required Qualifications
    • Extensive experience with Fill/Finish Technology Transfer.
    • Strong background in sterile pharmaceutical manufacturing.
    • Hands-on experience supporting Engineering, PPQ, Validation, and Commercial batches.
    • Expertise in Process Validation and Process Control Strategy.
    • Strong understanding of cGMP regulations and pharmaceutical manufacturing.
    • Excellent troubleshooting, leadership, and communication skills.
    Preferred Qualifications
    • Drug Product manufacturing experience.
    • Experience leading cross-functional technical teams.
    • Strong documentation review and technical writing support experience.

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