6469 - Automation CQV Engineer / Senior Automation Engineer

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

• →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. 

• 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.