Senior Automation Engineer, Optical Inspection​/Device Assembly

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Supply Chain Engineering

Automation Engineering

Scientific/Technology

Wilson, North Carolina, United States of America

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Reporting to the Drug Product Manufacturing Lead within the Site Automation organization, the Automation Engineer, Drug Product – Optical Inspection / Device Assembly provides technical automation and controls engineering ownership for the assigned inspection and device-assembly area. This is an automation engineering role with direct accountability for manufacturing control systems and automation delivery;
Process Engineering is a key partner but is not the functional scope of this position.

The Senior Automation Engineer, is responsible for the design, implementation, qualification, start-up, support, troubleshooting, and lifecycle management of automation solutions for Drug Product optical/visual inspection and device assembly operations and their interfaces to site manufacturing systems. The engineer will work closely with Manufacturing, Process Engineering, Quality, Computerized System Validation (CSV), OT Infrastructure, MES, Digital, equipment suppliers, OEM controls teams, and system integrators.

• Serve as the area Automation Engineer for Drug Product optical/visual inspection and device assembly and provide direct technical ownership of the automation/controls scope under the DP Manufacturing Lead.
• Support end-to-end automation delivery from concept and detailed design through controls development, FAT/SAT, construction support, commissioning, qualification, start-up, handover, troubleshooting, and steady-state lifecycle support.
• Provide technical oversight for automation solutions supporting optical and visual inspection, device assembly, robotics, machine controls, servo/motion control, vision/inspection systems, SCADA/HMI, industrial networks, and associated site-system interfaces.
• Review and challenge OEM and system-integrator automation designs, software/configuration, functional and design specifications, control narratives, system architectures, interface definitions, alarms/interlocks, inspection/vision-system requirements, and test documentation to ensure alignment with site and global automation standards.
• Develop, implement, review, and troubleshoot PLC/HMI, machine-control, motion, robotics, and vision/inspection-system changes within the assigned area; ensure software and configuration are maintainable, standardized, documented, and appropriately controlled.
• Plan, support, and execute automation FAT/SAT, commissioning, qualification, and start-up activities; lead technical issue resolution and drive automation punch-list items to closure.
• Support automation interfaces to MES, historian, recipe/data platforms, and other site systems; ensure reliable data flow, traceability, and system integration for inspection and device-assembly operations.
• Author, review, and execute automation-related validation and qualification documentation; support risk assessments, investigations, deviations, CAPA, change controls, and regulatory/internal inspections.
• Apply sound automation engineering principles, cGMP requirements, GAMP 5 practices, data-integrity expectations, cybersecurity controls, and lifecycle-management standards throughout the system lifecycle.
• Partner with Manufacturing and Process Engineering on process and equipment requirements while retaining technical ownership of the automation/controls solution. Translate approved requirements into robust, testable automation functionality.
• Coordinate technically with equipment vendors, OEM controls teams, system integrators, CSV, OT Infrastructure, MES, Digital, Quality, and other partners to deliver integrated and supportable inspection and…