Senior Manager Automation Lead

Johnson & Johnson Johnson & Johnson · Pharma · Raritan, NJ +1

Senior Manager Automation Lead for a CAR T manufacturing site, responsible for automation strategy, architecture, deployments, validation, and lifecycle support of industrial control systems, operational technology, and integration with enterprise systems in a regulated pharmaceutical environment.

What you'd actually do

  1. 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.
  2. Define and drive the site automation strategy and roadmap: standards, reference architectures, design patterns, and governance aligned to manufacturing and quality requirements.
  3. Lead delivery of automation projects from requirements through design, programming, factory and site acceptance testing, commissioning, CSV (IQ/OQ/PQ), and handover to operations.
  4. Responsible for architect, specify, and oversee the configuration and deployment of PLC/DCS, SCADA/HMI, and field instrumentation/I/O to support CAR‑T and Lenti process.
  5. 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.

Skills

Required

  • 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

Nice to have

  • 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

What the JD emphasized

  • regulated pharma/biotech manufacturing
  • GMP environments
  • GxP requirements
  • 21 CFR Part 11 concepts
  • regulatory expectations for automated systems