Automation Engineer​/Automation & Controls Specialist

Durham, NC - Full Time

Position Summary
The Automation Engineer provides technical support for automated manufacturing and inspection systems in a regulated environment. This role serves as a key escalation point for automation and controls issues, supports continuous operation of syringe filling and inspection equipment, and contributes to system enhancements, troubleshooting, validation, and compliance activities.

Key Responsibilities

Automation & Operational Support

Serve as the primary escalation point for automation and equipment control issues during syringe filling, inspection engineering activities, and manufacturing operations.

Rapidly respond to alarms, equipment faults, and automation‑related process deviations to minimize downtime and production impact.

Monitor automated system performance, trends, and logs to proactively identify reliability or control‑related concerns.

Collaborate with engineering peers to meet project deliverables and mitigate schedule risks.

Partner with manufacturing operators to ensure safe, compliant, and efficient automated production.

Troubleshooting, Controls, and Maintenance

Perform first‑line troubleshooting of PLCs, HMIs, servo systems, robotics, sensors, vision systems, pneumatics, and other control components.

Implement minor PLC and HMI code modifications following established engineering change control procedures.

Support deployment of automation updates, patches, and configuration changes.

Work closely with maintenance and engineering teams on complex repairs, advanced diagnostics, and planned shutdowns.

Document issues, corrective actions, and code changes in compliance with cGMP and site procedures.

Assist in the development, testing, and implementation of new PLC logic, HMI screens, alarms, and control strategies.

Support automation upgrades, including hardware replacements, system migrations, and new equipment integrations.

Identify and recommend improvements to enhance equipment reliability, process robustness, and operational efficiency.

Participate in engineering design reviews and provide automation‑related technical input.

Support commissioning activities for new or upgraded automated systems, including I/O checks, sequence testing, and functional verification.

Execute qualification and validation protocols such as FAT, SAT, IQ, and OQ in collaboration with engineering and quality teams.

Assist in the development of validation documentation, including test scripts, traceability matrices, and configuration records.

Ensure all automation changes comply with change control, risk assessment, and documentation requirements.

Compliance, Documentation & Technical Support

Maintain accurate and timely automation documentation, including code revisions, configuration backups, logbooks, and CMMS records.

Ensure compliance with cGMP, safety, environmental, and corporate engineering standards.

Support internal and external audits, inspections, and quality investigations.

Assist in training operations and maintenance personnel on updated automation systems, troubleshooting methods, and best practices.

Required Qualifications

Bachelor’s or Associate degree in Automation Engineering, Electrical Engineering, Mechatronics, Engineering Technology, or a related discipline; or equivalent relevant experience.

Strong hands‑on troubleshooting experience with PLCs, HMIs, motion control systems, pneumatics, and automated inspection systems.

Experience supporting automated systems in a regulated manufacturing environment (pharmaceutical, biotech, medical device, food/beverage, or similar).

Ability to interpret electrical schematics, P&IDs, machine drawings, and control system documentation.

Hands‑on experience with Rockwell PLC and HMI platforms.

Flexibility to work extended hours as required to meet operational and project objectives.

Preferred Qualifications

Experience with syringe filling equipment, aseptic manufacturing operations, or automated visual inspection systems.

Experience with Siemens, Beckhoff, or similar PLC/HMI platforms.

Knowledge of cGMP requirements, data integrity principles, and change control processes.

Experience executing or developing commissioning and validation protocols.

Strong communication, documentation, and cross‑functional collaboration skills.

Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.