Senior Automation Controls Engineer
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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.