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    Process Development Engineer - Santa Clara, United States - Dawar Consulting, Inc.

    Dawar Consulting, Inc.
    Dawar Consulting, Inc. Santa Clara, United States

    3 weeks ago

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    Description

    Our client, a top player in diagnostics and life sciences, is seeking a Process Development Engineer in Santa Clara, CA.


    Job Duration: Extended Contract (Possibility Of Extension)

    Role:
    • Offer hands-on process support including troubleshooting and enhancement initiatives
    • Develop and approve Work Instructions, Production Records, and other process documentation
    • Provide guidance on enhancements and ensure controls are demonstrated through method validation or computer system validation
    • Lead investigations for identified non-compliance observations such as Corrective and Preventative Actions (CAPAs) and Non-Conformance Reports (NCRs)

    Education/Required Skills:

    • BS in relevant field
    • 5-8 years in Medical Device or In Vitro Diagnostics
    • Experience in Cartridge manufacturing, microfluidic devices, or DNA Sequencing is preferred.
    • Prior expertise in process mapping, document creation, and testing in production settings is highly advantageous.
    • Familiarity with statistical analysis, DOE, and utilization of tools like Minitab for data interpretation.
    • Experience in raw material characterization, encompassing visual inspection, chemical testing, and surface analysis.
    • Proficient in process validation, equipment validation, and ensuring adherence to relevant standards and regulations.

    Company Benefits: Medical, Dental, Vision, Paid Sick leave, 401K

    To express interest, please submit your resume through the provided means.

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