Senior Automation Controls Engineer
About The Position
This role involves providing engineering and design support for automated systems, with a strong emphasis on regulatory compliance within a GMP environment. The engineer will be responsible for understanding and troubleshooting complex control systems, including PLCs, PC-based controllers, and vision inspection systems. Key responsibilities include defining requirements, reviewing vendor documentation, supporting system qualification, and preparing risk assessments and change controls. The position requires independent work with limited supervision and the ability to review the work of others. Flexibility to work off-shifts is also necessary to support a 3-shift operation.
Requirements
- Understand 21 CFR Part 11, cGMP, and other regulatory guidance associated with computer / automation-based systems.
- Working knowledge of vision inspection systems.
- Working knowledge of vision inspection systems and related quality processes in a GMP environment.
- Proficient in reading and interpreting electrical schematics for troubleshooting and repair.
- Managing projects / processes, working independently with limited supervision.
- 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.
Responsibilities
- 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.
- 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).
- Review qualification protocols of automated systems.
- Support the execution of the qualification of automated control systems.
- Prepare risk assessments for automated systems.
- Prepare Change Controls associated with changes to control systems.
- Reviewing the work of lower level professionals or contractors.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
