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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 world leader in diagnostics and life sciences, is looking for a Process Development Engineer based out of Santa Clara, CA.


    Job Duration: Long Term Contract(Possibility Of Extension)

    Responsibilities:
    • Provide hands-on process support including troubleshooting and improvement initiatives
    • Create and approve Work Instructions, Production Records, and other documentation for processes
    • Define and monitor process health metrics (KPIs, key performance indicators)
    • Support material qualification, supplier qualification, and actively manage issues found with incoming materials, development of Qualification and Validation plans
    • Leveraging best practices in production and testing excellence (i.e. LEAN practices and Design for Quality and Manufacturability)
    • Advise on improvements and ensure controls are demonstrated through completion of method validation, spreadsheet validation, or computer system validation
    • Support or lead investigations for identified non-compliance observations (for example, Corrective and Preventative Actions (CAPAs) and Non-Conformance Reports (NCRs)

    Education/Qualification:

    • BS in the relevant field
    • 5-8 years in Medical Device or In Vitro Diagnostics
    • Prior experience: Cartridge manufacturing, microfluidic devices or DNA Sequencing is preferred.

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

    Please apply or send your resume to /


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