Senior Automation Engineer, Drug Product–Aseptic Filling

Job Function:

Supply Chain Engineering

Automation Engineering

Scientific/Technology

Wilson, North Carolina, United States of America

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The Automation organization is a dedicated team of professionals with diverse technical expertise responsible for the implementation, validation, qualification, and lifecycle support of ISA-95 Level 1 and Level 2 manufacturing automation systems, applicable interfaces, and Level 3 recipe and manufacturing-system integration. The team ensures that automated systems are fit for intended use and comply with applicable regulatory requirements, company manufacturing standards, data-integrity expectations, and cybersecurity requirements throughout the system lifecycle.

Reporting to the Drug Product Manufacturing Lead within the Site Automation organization, the Automation Engineer, Drug Product – Aseptic Filling provides technical automation and controls engineering ownership for the assigned aseptic filling 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 role is responsible for the design, implementation, qualification, start-up, support, troubleshooting, and lifecycle management of automation solutions for Drug Product aseptic filling 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 aseptic filling 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 aseptic filling/finish operations and associated highly automated Drug Product equipment, including applicable isolator or barrier technologies, machine controls, batch/sequence control, SCADA/HMI, industrial networks, robotics, and 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, and test documentation to ensure alignment with site and global automation standards. Develop, implement, review, and troubleshoot PLC/DCS/HMI/batch and machine-control 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. Travel domestically and internationally, as required, to supplier/OEM, system-integrator, and Johnson & Johnson affiliate sites for FAT, technical training, knowledge transfer, and automation readiness. Support automation interfaces to MES, historian, recipe/data platforms, and other site systems; ensure reliable data flow, traceability, and system integration for Drug Product manufacturing operations.

Author, review, and execute automation-related validation and qualification documentation; support risk assessments, investigations, deviations, CAPA, change controls, and regulatory/internal…