About this role
• 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.