Senior Automation Controls Engineer

Renaissance Lakewood

  • Lakewood, New Jersey
  • 29 days ago

    Highlights

    Review vendor automation design documentation (FRS, DDS, requirements traceability matrix, code, and logic). Understand 21 CFR Part 11, cGMP, and other regulatory guidance associated with computer / automation-based systems.

    Numbers & Facts

    LocationLakewood, New Jersey

    Description

    • Understand 21 CFR Part 11, cGMP, and other regulatory guidance associated with computer / automation-based systems.
    • Provide support for the engineering and design of automated systems.
    • Understand and read complex ladder logic.
    • Understand PLC/ PC based controllers and functionality.
    • Troubleshoot low voltage control wiring.
    • Working knowledge of vision inspection systems.
    • Troubleshoot filling and packaging equipment.
    • Define requirements for vendor design documentation.
    • Generate user requirement specifications for control systems.
    • Review vendor automation design documentation (FRS, DDS, requirements traceability matrix, code, and logic).
    • Working knowledge of vision inspection systems and related quality processes in a GMP environment.
    • Review qualification protocols of automated systems.
    • Support the execution of the qualification of automated control systems.
    • Proficient in reading and interpreting electrical schematics for troubleshooting and repair.
    • Managing projects / processes, working independently with limited supervision.
    • Reviewing the work of lower level professionals or contractors.
    • Prepare risk assessments for automated systems.
    • Prepare Change Controls associated with changes to control systems.
    • Able to perform complex assessments for computer systems against current industry compliance requirements.
    • Be flexible to work on off-shifts as needed to support a 3 shifts operation.

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