Automation Engineer Syringe Manufacturing Formulation Equipment Cleaning Filling Inspection Ope

Position Overview

We are seeking a skilled and highly motivated Automation Engineer to support syringe filling and inspection operations at our Durham, NC facility. This is a hands-on, frontline engineering role in a fast-paced, highly regulated manufacturing environment.

The Automation Engineer will act as the primary responder for automation and controls issues , supporting PLC/HMI systems, troubleshooting equipment faults, implementing code changes, and contributing to equipment commissioning, upgrades, and validation activities. This role works closely with Operations, Maintenance, Quality, and Engineering teams to ensure safe, compliant, and efficient production.

• Serve as the escalation point for automation and equipment control issues during syringe filling and inspection operations.

• Respond promptly to alarms, faults, and automation-related deviations to minimize downtime.

• Monitor system performance, trends, and logs to identify emerging reliability or control issues.

• Collaborate with engineers and operators to maintain safe, compliant, and efficient automated production.

• Perform first-line troubleshooting on PLCs, HMIs, servo systems, robotics, sensors, vision systems, pneumatics, and related controls.

• Implement minor PLC/HMI code modifications following approved change control procedures.

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

• Partner with Maintenance and Engineering teams on complex troubleshooting and planned shutdowns.

• Document issues, corrective actions, and code changes in compliance with cGMP requirements.

• Support development, testing, and implementation of PLC logic, HMI screens, alarms, and control strategies.

• Assist with automation upgrades, hardware replacements, system migrations, and new equipment integration.

• Identify opportunities to improve equipment reliability, process robustness, and operational efficiency.

• Participate in engineering design reviews and provide automation technical input.

• Support commissioning activities including IO checks, sequence testing, and functional verifications.

• Execute FAT, SAT, IQ, and OQ protocols in collaboration with Engineering and Quality.

• Assist in developing validation documentation such as test scripts, traceability matrices, and configuration records.

• Ensure all automation changes follow approved change control and risk assessment processes.

• Maintain accurate automation documentation including code backups, configuration records, logbooks, and CMMS entries.

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

• Support audits, inspections, and quality events.

• Assist with training operators and maintenance personnel on automation updates and troubleshooting best practices.

• Associate or Bachelor's degree in Automation Engineering, Electrical Engineering, Mechatronics, Engineering Technology, or equivalent experience.

• Strong hands-on troubleshooting experience with PLCs, HMIs, motion control, and automated manufacturing systems.

• Experience supporting automation in regulated manufacturing environments (pharma, biotech, medical device, food, or beverage).

• Ability to read and interpret electrical schematics, P&IDs, and control system documentation.

• Hands-on experience with Rockwell PLC/HMI platforms
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• Flexibility to work extended hours as required to support operations and projects.

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

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

• Knowledge of cGMP, data integrity, and change control processes.

• Experience executing or developing commissioning and validation protocols.

• Strong communication, documentation, and cross-functional collaboration skills.

• Regular presence on the production floor, including classified cleanroom environments.

• Use of PPE according to area classification and task requirements.

• Physical activities may include standing for extended periods, bending, climbing, and lifting moderate weights.