Sr. Automation Controls Engineer

The Sr. Automation Controls Engineer will be responsible for installing, maintaining, and troubleshooting the automation systems for automated utility, processing, filling, inspection and packaging equipment. System will be PLC, SCADA, and PC based.

The individual will be expected to perform system administration (access control, software revision control, back-up and recovery), and perform trouble shooting for malfunctioning systems.
The individual will be responsible for reviewing functional specifications for both hardware and software for new automated utility, process, filling, and packaging and inspection equipment.
Individual must be capable of reading and understanding electrical control system diagrams (control panel wiring diagrams, loop drawings, panel layout drawings and schedules, etc.). Individual must be comfortable walking down control system diagrams and red-lining them to reflect as built conditions. ACAD and networking experience a plus, but not an absolute requirement
Once installed, the individual will be responsible for performing IQ/OQ/PQ on the system operation and maintaining compliance to site procedures.
Understand 21 CFR Part 11, cGMP, and other regulatory guidance associated with computer / automation-based systems.
Generate user requirement specifications for control systems.
Define requirements for vendor design documentation.
Review vendor automation design documentation (FRS, DDS, requirements traceability matrix, code and logic, etc.).
Provide support for engineering and design of automated systems
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
May supervise junior engineers, process mechanical staff, electrical and automation contractors as well as Maintenance mechanics, Contract Engineers and Construction Contractors.
Perform other duties and responsibilities as assigned.

Bachelor’s Degree in Electrical Engineering, Computer Science or related discipline required.
5+ experience of vision systems, software development, integration, testing and validation; project management of automated manufacturing systems
Experience with medical device and/or pharmaceutical production required (cGMP / FDA regulated environment). Confident in configuring Excel spreadsheet, spreadsheet functions and automated calculations. Familiarity with current industry practices and guidelines including those required / outlined by the FDA, ISO, EU and ICH.

Experience with major component vendors such as Keyence, Cognex, and Seidenador required. Experience with major PLC vendors such as Allen Bradley, Beckman, and Siemens required.