Automation CQV Engineer

Location: Devens, MA | Duration: Contract

About the Role

We are seeking an Automation CQV Engineer / Senior Automation Engineer to provide technical oversight and hands-on support for vendor-controlled bioprocess equipment. The role will evaluate controls configuration, vendor programming, system behavior, and equipment performance against approved process and functional requirements. The engineer will serve as the technical bridge between equipment vendors, Process Engineering, CQV, CSV, and Quality teams.

Responsibilities

• Review PLC, HMI, SCADA, and overall controls architecture for TFF skids, bioreactors, and chromatography systems.
• Review functional specifications, control narratives, sequence descriptions, and I/O documentation.
• Evaluate vendor programming and configuration against approved requirements.
• Support authorized minor PLC/HMI configuration and programming changes.
• Review recipes, methods, phases, sequences, and process transitions.
• Support PID loop tuning, analog/digital I/O verification, and field troubleshooting.
• Test alarms, interlocks, permissives, equipment states, failure responses, and recovery sequences.
• Troubleshoot communication between controllers, HMIs, instruments, and local databases.
• Support FAT, SAT, commissioning, and OQ activities.
• Review vendor test evidence and identify gaps or unsupported results.
• Support CSV testing and verification of system configuration and computerized controls.
• Assist with discrepancy investigations, root-cause analysis, change control, and configuration management.

Qualifications

• Bachelor’s degree in Automation, Electrical, Chemical, Computer Engineering, or related discipline.
• 5+ 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 activities.
• Strong understanding of PID control and analog process instrumentation.
• Strong troubleshooting and cross-functional communication skills.
• Ability to independently review and challenge vendor designs, test results, and solutions.

Skills

• Direct experience with UNICORN, KlariFi, or Lucullus.
• Experience with KrosFlo/TFF systems, bioreactors, or chromatography equipment.
• Experience with Allen-Bradley, Siemens, or comparable PLC platforms.
• Knowledge of OPC / OPC UA and equipment-level communications.
• Familiarity with GMP change control and CSV requirements.
• Experience making controlled minor PLC/HMI programming or configuration modifications.