Automation Engineer / Automation & Controls Specialist

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.

Automation Development & System Enhancements

• 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.

Commissioning, Qualification & Validation

• 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.