Senior Manager Automation Lead

About the role

At Johnson & Johnson, we are seeking a Senior Manager, Automation to lead automation engineering, operational technology (OT), and control systems for the Raritan CAR T manufacturing site. This role combines people leadership with deep technical expertise in industrial control systems, integration, commissioning, and regulated system validation.

Responsibilities

• Provide direct leadership and development for a team of automation and OT engineers; establish hiring priorities, performance objectives, and a culture of accountability and continuous improvement.
• Define and drive the site automation strategy and roadmap: standards, reference architectures, design patterns, and governance aligned to manufacturing and quality requirements.
• Lead delivery of automation projects from requirements through design, programming, factory and site acceptance testing, commissioning, CSV (IQ/OQ/PQ), and handover to operations.
• Accountable for the site process historian—ensuring continuous, secure, validated capture and availability of time-series process and event data to support traceability, operations, analytics, and regulatory compliance.
• Ensure integration of control systems with enterprise and manufacturing systems (MES, LIMS, ERP/WMS) through robust, validated interfaces while maintaining chain-of-identity and chain-of-custody requirements.
• Represent the automation function during regulatory inspections and audits.
• Monitor automation performance and support continuous improvement, and lifecycle management.

Qualifications

• Education: Minimum of a Bachelor’s degree is required, focused degree in Engineering, Computer Science, or related technical discipline and/or Master’s degree preferred.
• Required Skills and Experience: Minimum 10 years’ experience in industrial automation, control systems, and OT/IT integration; minimum 5 years in regulated pharma/biotech manufacturing.
• Demonstrated experience implementing and validating automation and control systems in GMP environments.
• Strong hands-on knowledge of PLC/DCS programming and architectures (examples: Rockwell, Siemens, or equivalent), SCADA/HMI platforms, industrial networking (Ethernet/IP, PROFINET), and field instrumentation.
• Solid understanding of GxP requirements, 21 CFR Part 11 concepts, and regulatory expectations for automated systems.
• Experience managing multi-disciplinary automation projects from concept through sustained operation, including vendor management and budget responsibility.
• Strong leadership and stakeholder management capabilities.

Preferred

• Direct experience with cell therapy, ATMP, or biologics manufacturing automation.
• Experience integrating control systems with MES, LIMS, ERP (e.g., SAP), WMS, and clinical systems.
• Familiarity with robotics and automated material handling solutions.
• Knowledge of ISPE GAMP5 guidance and industrial cybersecurity frameworks.