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    Validation Engineer - Irvine, United States - Compunnel Inc.

    Compunnel Inc.
    Compunnel Inc. Irvine, United States

    3 weeks ago

    Default job background
    Description

    Job Description: The main function of a validation engineer is to apply quality and regulatory standards to equipment and process qualification. A typical validation engineer has the ability to perform statistical analysis, monitor process qualification activities, perform root-cause analysis for any protocol deviations or failures, and compile process qualification reports.

    Job Responsibilities:


    • Interpret engineering drawings, schematic diagrams, or formulas and confer with management or engineering staff to determine quality and reliability standards as well as ensure accuracy of process qualification specifications.


    • Read worker logs, product processing sheets, and specification sheets, to verify that records adhere to quality assurance and protocol specifications.


    • Aid in planning work assignments in accordance with worker performance, machine capacity, production schedules, and anticipated delays.


    • Prepare charts, graphs, and diagrams to illustrate workflow, routing, floor layouts, material handling, and machine utilization.


    • Observe worker using equipment to verify that equipment is being operated and maintained according to quality assurance standards.


    • Evaluate data and write reports to validate or indicate deviations from existing standards.

    Skills:


    • Creativity, verbal and written communication skills, analytical and problem solving ability.


    • Team player and detail oriented.


    • Ability to perform statistical analysis and draw meaningful conclusions.


    • Packaging and Sterile barrier validation experience is a plus


    • Ability to read and interpret blueprints, technical drawing, schematics and computer-generated reports.

    Education/Experience:


    • Bachelor's degree in engineering required.


    • 3-5 years experience required.

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