6469 - Automation CQV Engineer / Senior Automation Engineer

About the Role

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 requires 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.

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.

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.

Qualifications

• 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.

Pay

National (US) Range: $85,000 USD - $140,766 USD. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice.

Benefits

• Competitive pay plus performance-based incentive programs.
• Company-paid Life, Short-Term, and Long-Term Disability Insurance.
• Medical, Dental & Vision insurances.
• FSA, DCARE, Commuter Benefits.
• Supplemental Life, Hospital, Critical Illness, and Legal Insurance.
• Health Savings Account.
• 401(k) Retirement Plan (Employer Matching benefit).
• Paid Time Off (Rollover Option) and Holidays.
• As Needed Sick Time.
• Tuition Reimbursement.
• Team Social Activities.
• Employee Recognition.
• Employee Referral Program.
• Paid Parental Leave and Bereavement.

Company Culture & Values

• 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.