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    Validation Engineer - Irvine, United States - TalentBurst, an Inc 5000 company

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    Description

    Position: Senior Validation Engineer, Req#: 6910-1

    Location: Irvine, California (Onsite)

    Duration: 6+ Months Contract

    Job Description:

    The primary role of a validation engineer is to apply quality and regulatory standards to equipment and process qualification, including statistical analysis, monitoring process qualification activities, root-cause analysis for protocol deviations or failures, and compiling qualification reports.

    Education and Experience:

    • Bachelor's degree in engineering required
    • 3-5 years of relevant experience

    Skills:

    • Creativity, strong verbal and written communication skills, analytical thinking, problem-solving ability
    • Team player, detail-oriented
    • Proficient in statistical analysis and forming meaningful conclusions
    • Experience in Packaging and Sterile barrier validation is advantageous
    • Ability to interpret blueprints, technical drawings, schematics, and reports

    Key Responsibilities:

    • Interpret engineering drawings, diagrams, formulas, and collaborate with management or engineering staff to establish quality and reliability standards
    • Review worker logs and production sheets to ensure compliance with quality assurance specifications
    • Assist in planning work assignments based on worker performance, machine capacity, and production schedules
    • Create visual representations to demonstrate workflow, floor layouts, and machine utilization
    • Observe equipment operation to confirm adherence to quality standards
    • Analyze data and generate reports to validate or identify deviations from established standards

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