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    MES Engineer - Devens, MA, United States - Pharmatek Consulting Inc

    Pharmatek Consulting Inc
    Pharmatek Consulting Inc Devens, MA, United States

    1 day ago

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    Description
    MES Engineer (Syncade) Job Opportunity at a leading Company

    Location: 50% Onsite, Devens MA, 50% Remote

    Responsibilities:
    - Convert Single Use Facility (SUF) from Paper Batch Record to electronic batch record using MES 3.0
    - Convert MES 1.x in LSCC to MES 3.0 as part of MES NextGen project
    - Author, edit, and review CSV life cycle documentation (VP, RA, RCA, TM, VSR) and system specifications (URS, FRS, DS, CSs)
    - Design and deploy intermediate to high complexity equipment
    - Program and configure all products, including highly custom equipment
    - Develop and test new feature requirements for next-generation products
    - Resolve complex automation design challenges by diving into design programming, sequencing, and electrical signaling issues
    - Troubleshoot and test higher complexity PLC programming
    - Review functional specifications for new automated utility, process, filling, packaging, and inspection equipment
    - Prepare a preferred vendor list for control system hardware
    - Specify and troubleshoot instrumentation
    - Perform duties as the client Automation Department representative on a capital project

    Candidate Requirements:
    - 50% onsite requirements
    - Must work onsite in Devens, MA
    - Demonstrated work history as a Senior Automation Engineer
    - Bachelor's Degree in Engineering or Scientific field, preferably in Electrical Engineering Technology, Computer Engineering, or related field
    - Experience in working with and programming/commissioning/validating MES software platforms
    - Exposure to FDA regulated environments, including validation experience
    - Understanding of 21 CFR Part 11, GAMP 5, and other regulatory guidance for computer/automation-based systems
    - Previous project management experience
    - Experience with OSI PI

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