Automation Engineering Manager, Drug Product Manufacturing Lead

Automation Engineering Manager, Drug Product Manufacturing Lead

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

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.

Key Responsibilities:

• 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 assessments, investigations, deviations, corrective and preventive actions, and timely remediation activities related to Drug Product automation systems.
• Manage project cost, quality, schedule, scope, resources, and risk; remove obstacles, maintain accurate execution plans, and raise key decisions or issues to senior business and project team members as needed.
• Build effective partnerships with Manufacturing, Process Engineering, Quality, Computerized System Validation, OT Infrastructure, MES, BAS and Utilities, Lab Systems, Procurement, Digital, and other cross-functional partners.
• Serve as the primary Drug Product automation point of contact for the site and ensure integrated delivery with process, equipment, digital, and manufacturing teams.
• Define, monitor, and report meaningful metrics and key performance indicators for project delivery, system performance, compliance, reliability, and lifecycle health.
• Lead technical selection, alignment, performance management, and delivery governance for automation suppliers, OEM controls teams, system integrators, and automation service providers.
• Ensure supplier designs, software, and integration work align with site automation architecture, standards, cybersecurity, validation, and lifecycle requirements.
• Develop and maintain reusable…