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    sr. validation engineer - Allentown, United States - JSat Automation Inc

    JSat Automation Inc
    JSat Automation Inc Allentown, United States

    2 weeks ago

    Default job background
    Description
    JSat Automation is hiring a Senior Automation Validation Engineer.

    This Engineer will be responsible for the following:
    Responsibilities

    Lead the designing and development of manufacturing control systems in support of process operations.
    Interact with client personnel to identify and analyze continuous improvement through automation upgrades.
    Manage or support projects as the primary controls resource.
    Develop validation documents per FDA cGMP and GAMP standards, functional specifications, design specifications and requirements trace matrices.
    Design, program, test and validate process control automation systems.
    Prepare and execute validation protocols (AIQ, IQ, OQ) for 21 CFR Part 11 compliance per FDA requirements.
    Manage, document, and implement these upgrades through changes control procedures.

    Manage the activities of on-site project resources; define detailed plan necessary to complete approved projects on schedule and within budget.

    Design, develop, and implement technical solutions by establishing integration strategies, configuring, and programming PLCs, DCSs as well as design, build, install and integrate automation control system hardware, panels, and field devices.

    Manage capital projects including but not limited to:

    Control system hardware design
    Network design
    Control system software development
    MES system implementation
    Recipe management
    User requirement specification development
    Process equipment installations
    SOP development and training on Automation Systems
    Troubleshoot, analyze, and resolve field control system issues
    Develop, review, and / or execute automation qualification and validation protocols.

    Qualifications

    We require a minimum BS Degree in Engineering (Computer Science, Electronics, Electrical, Chemical, etc.) or equivalent with over 5 years' experience in process industry.

    Experience/Knowledge of selecting, designing and programming automation control systems. Startup and commissioning of DCS, Batch, PLC and SCADA systems using distributed I/O.
    Experience in Control Systems

    DeltaV
    Experience

    with SCADA, MES, and database systems, or computer system validation are considered a plus.
    Project Management experience and Process Knowledge is a plus

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