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Senior Automation Controls Engineer

Job Description - Senior Automation Controls Engineer


  • 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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