• 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.