What are the responsibilities and job description for the Automation Engineer or Controls Engineer position at Renaissance Lakewood, LLC?
- Understand 21 CFR Part 11, cGMP, and other regulatory guidance associated with computer / automation-based systems.
- Generate user requirement specifications for control systems.
- Working knowledge of vision inspection systems and related quality
- Define requirements for vendor design documentation.
- Review vendor automation design documentation (FRS, DDS, requirements traceability matrix, code and logic, etc.).
- Provide support for the engineering and design of automated systems
- 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.
- Walk down control panel drawings.
- Understand and read complex ladder logic
- Understand PLC-based controllers and functionality
- Troubleshoot on low voltage control wiring
- 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
