Automation & Controls Engineer – Bioprocess
Location: Devens, MA – 100% Onsite
Duration: August 2026 – July 2027
Employment Type: Contract
Position Overview
We are seeking an experienced Automation & Controls Engineer to support vendor-controlled bioprocess equipment within a GMP pharmaceutical/biotechnology manufacturing environment.
The ideal candidate is a hands-on Controls/Automation Engineer with strong PLC, HMI, SCADA/DCS, process controls, and equipment troubleshooting experience, combined with exposure to FAT, SAT, commissioning, qualification, and validation activities.
This engineer will serve as the technical bridge between equipment vendors, Process Engineering, Automation, CQV, CSV, Validation, and Manufacturing teams.
Key Responsibilities
- Review automation and controls architecture for bioprocess equipment, process skids, TFF systems, bioreactors, and associated equipment.
- Review and evaluate PLC, HMI, SCADA/DCS designs and vendor automation configurations.
- Review Functional Specifications, Design Specifications, Control Narratives, I/O Lists, sequence descriptions, and equipment documentation.
- Evaluate vendor programming and configuration against approved functional and process requirements.
- Troubleshoot PLC, HMI, SCADA/DCS, instrumentation, controller, and equipment communication issues.
- Verify alarms, interlocks, permissives, equipment states, process sequences, recipes, and automated startup/shutdown sequences.
- Perform and support I/O checks, loop checks, equipment testing, and field-device troubleshooting.
- Support PID loop tuning and process-control optimization.
- Support authorized minor PLC/HMI configuration or programming modifications.
- Participate in FAT, SAT, commissioning, startup, and Operational Qualification (OQ) activities.
- Support IQ/OQ, qualification, validation, and computerized system validation (CSV) testing.
- Review vendor test documentation and identify gaps, discrepancies, or unsupported conclusions.
- Support deviation investigations, root-cause analysis, CAPA, and GMP change-control activities.
- Maintain automation configuration documentation and support change-management activities.
- Work closely with equipment vendors, Process Engineering, CQV, CSV, Validation, Quality, and Manufacturing teams.
Required Qualifications
- Bachelor's degree in Automation Engineering, Electrical Engineering, Chemical Engineering, Computer Engineering, or a related engineering discipline.
- 5+ years of Automation, Controls, Process Controls, or computerized equipment experience within pharmaceutical, biotechnology, biopharmaceutical, or other GMP-regulated manufacturing environments.
- Hands-on experience with PLC/HMI/SCADA/DCS-controlled process equipment.
- Strong understanding of PLC logic, control narratives, I/O lists, automated process sequences, alarms, interlocks, permissives, and PID control.
- Experience supporting FAT, SAT, commissioning, qualification, IQ/OQ, and validation activities.
- Experience troubleshooting automation and controls systems in a GMP-regulated manufacturing environment.
- Ability to review and technically challenge vendor automation designs, programming, configurations, and test results.
- Strong technical communication and cross-functional collaboration skills.
Preferred Qualifications
- Experience with Emerson DeltaV or other DCS platforms.
- Experience with UNICORN, KlariFi, or Lucullus.
- Experience with KrosFlo/TFF systems, bioreactors, chromatography, fermentation, or other bioprocess equipment.
- Experience with Allen-Bradley/Rockwell or Siemens PLCs.
- Knowledge of OPC/OPC UA, Ethernet/IP, or industrial equipment communications.
- Experience with GAMP 5, 21 CFR Part 11, GMP change control, and CSV.
- Experience making controlled PLC/HMI configuration modifications.
- Experience working with vendor-controlled equipment and supporting equipment integration.
Ideal Candidate Profile
The ideal candidate is not purely a CQV/Validation Engineer. We are looking for someone with a strong Controls/Automation Engineering foundation who can understand and troubleshoot the actual control system and also support the associated commissioning and qualification activities.
Candidates with backgrounds such as the following are encouraged to apply:
Automation Engineer | Controls Engineer | Process Controls Engineer | Automation & Controls Engineer | Control Systems Engineer | DeltaV Engineer | DCS Engineer | Process Automation Engineer
Experience in pharmaceutical, biotechnology, biopharmaceutical, or GMP manufacturing is strongly preferred.
Pay: $48.00 - $52.00 per hour
Work Location: In person
