6469 - Automation CQV Engineer / Senior Automation Engineer

Job Overview: We are seeking an Automation and Controls CQV Engineer to provide independent technical oversight and hands-on support for vendor-controlled bioprocess equipment. This role does not necessarily require a full-time software developer, but it does require someone who can understand the controls configuration, evaluate vendor programming, troubleshoot system behavior and confirm that the equipment operates in accordance with approved process and functional requirements. The engineer will act as the technical bridge between the equipment vendor, Process Engineering, CQV and CSV teams.

Senior Automation Engineer Responsibilities:

• Review the controls architecture for the TFF skid, bioreactor and associated systems. 
• Review PLC, HMI and SCADA design and configuration documentation. 
• Review functional specifications, control narratives, sequence descriptions and I/O lists. 
• Evaluate vendor programming and configuration against approved requirements. 
• Support or perform minor PLC/HMI configuration changes when authorized. 
• Review recipe, method, phase and sequence configuration. 
• Support PID-loop tuning and process-control optimization. 
• Verify analog and digital I/O behavior. 
• Support loop checks and field-device troubleshooting. 
• Challenge alarms, interlocks, permissives, equipment states and failure responses. 
• Verify startup, shutdown, hold, abort and recovery sequences. 
• Support recipe-transition and exception-path testing. 
• Review alarm priorities, limits, delays and operator messages. 
• Troubleshoot communications among controllers, HMIs, instruments and local databases. 
• Support FAT, SAT, commissioning and OQ execution. 
• Provide technical support during CSV testing of access controls, audit trails, records and configuration. 
• Review vendor test evidence and identify gaps or unsupported conclusions. 
• Support discrepancy investigation and root-cause analysis. 
• Maintain configuration control and support change-management documentation. 

Job Requirements:

• Bachelor’s degree in Automation Engineering, Electrical Engineering, Chemical Engineering, Computer Engineering or a related discipline. 
• Approximately five or more years of automation, controls or computerized-equipment experience in pharmaceutical or biotechnology manufacturing. 
• Hands-on experience with PLC/HMI- or SCADA-controlled process equipment. 
• Ability to review PLC logic, control narratives, I/O lists and sequence documentation. 
• Experience testing alarms, interlocks, permissives, recipes and automated process sequences. 
• Experience supporting FAT, SAT, commissioning or qualification testing. 
• Understanding of PID control and analog process instrumentation. 
• Ability to independently challenge vendor designs, test results and proposed solutions. 
• Strong troubleshooting and cross-functional communication skills.
• Direct experience with UNICORN, KlariFi or Lucullus. 
• Experience with KrosFlo/TFF systems, bioreactors or chromatography equipment. 
• Experience with Allen-Bradley, Siemens or comparable vendor PLC platforms. 
• Experience with OPC, OPC UA or equipment-level communications. 
• Familiarity with GMP change control and computerized-system validation. 
• Experience making controlled, minor programming or configuration modifications.

This role requires the ability to be on-site, full-time in Devens, MA.