Senior Automation Engineer, Drug Product–Aseptic Filling

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 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

while retaining technical ownership of the automation/controls solution. Translate approved process and equipment

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 an integrated and supportable solution.
• ✓Support operational readiness through training, documentation, maintenance/support models, spare-parts considerations, disaster-recovery/business-continuity planning, and transfer of automation-