Automation Engineer

We are seeking an experienced Automation Engineer to support automation and control systems within a regulated biotech/pharmaceutical manufacturing environment in North Carolina. The ideal candidate will have hands-on experience with PLC, HMI/SCADA, process automation, equipment integration, and troubleshooting in a GMP manufacturing facility.

The Automation Engineer will work closely with Manufacturing, Engineering, Maintenance, Validation, Quality, and IT/OT teams to maintain and improve automated manufacturing systems while ensuring compliance with GMP and data integrity requirements
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• Support, troubleshoot, and maintain automation and control systems used in biotech/pharmaceutical manufacturing.
• Develop, modify, and troubleshoot PLC programs, HMI applications, and SCADA systems
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• Support Allen-Bradley Control Logix/Compact Logix PLCs and Factory Talk View HMI/SCADA platforms.
• Participate in automation system commissioning, startup, FAT, SAT, and equipment integration activities.
• Support automation activities for bioreactors, fermenters, chromatography systems, TFF systems, CIP/SIP systems, utilities, and other process equipment
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• Interface with process equipment, instrumentation, MES, historians, and other manufacturing systems.
• Troubleshoot controls, instrumentation, communication, and network-related issues affecting manufacturing operations.
• Work with CQV/Validation teams to support IQ/OQ/PQ, commissioning, and qualification activities
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• Review and develop automation specifications, functional requirements, control narratives, SOPs, and technical documentation.
• Support automation changes through appropriate change control, deviation, CAPA, and documentation processes
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• Ensure automation systems operate in accordance with GMP, GxP, FDA, and site quality requirements
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• Collaborate with vendors and system integrators during equipment installation, commissioning, troubleshooting, and upgrades.
• Support continuous improvement initiatives involving process automation, equipment reliability, and manufacturing efficiency.
• Participate in system upgrades, migrations, and automation improvement projects.

• Bachelor's degree in Electrical Engineering, Automation Engineering, Controls Engineering, Chemical Engineering, or related field
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• 3+ years of automation/controls engineering experience in biotech, pharmaceutical, life sciences, or other GMP-regulated manufacturing environments.
• Hands-on experience with PLC programming and troubleshooting
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• Experience with Allen-Bradley Control Logix/Compact Logix and Factory Talk View ME/SE
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• Experience with HMI/SCADA systems and industrial communication protocols.
• Understanding of GMP/GxP requirements and automation systems used in regulated manufacturing.
• Experience supporting equipment commissioning, startup, FAT/SAT, and troubleshooting.
• Ability to work effectively with Engineering, Manufacturing, Maintenance, Quality, Validation, and vendors.
• Strong troubleshooting, documentation, and communication skills.

• Experience with Emerson DeltaV or other DCS platforms.
• Experience with .
• Experience with MES
  , Historian, SQL, or manufacturing data systems.
• Experience with bioreactors, TFF, chromatography, CIP/SIP, buffer/media preparation, and upstream/downstream processing equipment
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• Experience supporting CQV/CSV and validation activities
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• Knowledge of 21 CFR Part 11, GAMP 5, and data integrity principles
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• Experience with automation system cybersecurity and OT networks.
• Experience with Python or other scripting languages is a plus.