Automation Engineering Manager, Drug Product Manufacturing Lead

Supply Chain Engineering

Automation Engineering

People Leader

Wilson, North Carolina, United States of America

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Reporting to the Site Automation Lead, the Automation Engineering Manager, Drug Product Manufacturing Lead provides technical and organizational leadership for Drug Product automation. This is an automation engineering leadership role with direct accountability for manufacturing controls and automation systems;
Process Engineering is a key partner but is not the functional scope of this position. The role is accountable for the automation strategy, architecture, design, delivery, qualification, start-up, operational readiness, support, and lifecycle management of automation solutions across formulation, aseptic filling, optical and visual inspection, device assembly, packaging, robotics, material handling, and associated manufacturing interfaces.

The new facility and production processes are envisioned to be highly automated, with data shared across multiple platforms to support production from material receipt through formulation, aseptic filling, inspection, device assembly, packaging and final product disposition. Data generated at each stage of production will be shared across business information and control systems to support process monitoring, advanced analytics, predictive models, operational decision-making, and disposition support.

• Lead, coach, and develop the Drug Product automation team and extended delivery organization, including automation engineers, controls engineers, system integrators, OEM automation teams, and contractors; provide resource planning, technical direction, capability development, performance alignment, and delivery accountability.

• Define and implement the Drug Product automation strategy, technical scope, control-system architecture, standards, software and configuration practices, and lifecycle roadmap; ensure the resources, governance, and processes required for successful automation delivery are in place.

• Provide end-to-end automation engineering leadership from concept and detailed design through controls development, FAT/SAT, construction support, commissioning, qualification, start-up, handover, troubleshooting, and steady-state lifecycle support.

• Lead the technical design authority for Drug Product automation solutions supporting formulation, aseptic filling, optical and visual inspection, device assembly, packaging, robotics, and material handling.

• Provide technical oversight of PLC/DCS control systems, SCADA/HMI, batch control, machine and motion control, vision/inspection systems, robotics, industrial networks, OT infrastructure, and interfaces with MES, historians, and other site systems.

• Review and approve automation engineering work, including control strategies, functional and design specifications, control narratives, system architectures, interface definitions, software/configuration standards, FAT/SAT protocols, commissioning and qualification documentation, and automation change controls.

• Ensure automation work and system lifecycle practices comply with global standards, cGMP requirements, GAMP 5 expectations, data integrity principles, cybersecurity controls, and applicable validation requirements.

• Support inspections, risk…