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Marquand

    Lead Validation Engineer - Indianapolis, United States - Katalyst HealthCares & Life Sciences

    Katalyst HealthCares & Life Sciences
    Katalyst HealthCares & Life Sciences Indianapolis, United States

    4 weeks ago

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    Description
    Responsibilities:
    • For Automation Engineers who are assigned to validation projects and operate in the field, the engineer may participate in validation activities.
    • Responsible for design and implementation of key automation aspects of an equipment project, often including PLC, vision, HMI programming.
    • Design of electrical panel(s).
    • Design and PLC programming (configuration of PLC program) on standard equipment/products.
    • Vision programming (custom) and configuration primarily for Insight, Spectrum and Prism products.
    • Lead and perform complex quality checks which require an intricate understanding of the machine control systems and operations.
    • Owns and manages the Bill of Materials.
    • Responsible for installing, maintaining, and troubleshooting automated utility, processing, filing, inspection, and packaging equipment.
    • Generate user requirement specifications for control systems.
    • Able to make minor modifications to code and HMI graphics for smaller changes.
    • Must be able to read logic and perform programming as well as update control system documentation.
    • Contribute technical content to validation protocols on automation systems and perform execution of protocols.

    Requirements:

    • Bachelor's Degree (Engineering or Scientific). Preferred area of study in Electrical Engineering Technology, Computer Engineering, or similar study.
    • Experience working with and programming Emerson Syncade and Delta V software platforms.
    • Exposure to FDA regulated environments including validation experience.
    • Understand 21 CFR Part 11, GAMP 5, and other regulatory guidance associated with computer/automation-based systems.
    • Previous project management experience.
    • Recipe configuration
    • Develop and perform integration testing.
    • Develop and perform functional testing.
    • Troubleshooting experience on customer shop floor.
    • Technical understanding and experience with automated equipment for manufacturing, device assembly, and packaging (PLCs, HMIs, PC based controls).
    • Capacity to make independent sound decisions and independently manage priorities.
    • Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate with others.
    • Experience with and tolerance for high levels of challenge and change.
    • Experience and capability of effectively communicating requirements (written and orally) with rationale to different levels of the organization (C-Level required for higher level Automation Engineer).
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