OT Manufacturing Engineer – Industrial Controls & Automation

Johnson & Johnson Innovation; Santa Clara (CA); On-site; USD 109,000 - 175,000; Full time

Job summary

Johnson & Johnson Innovation is seeking a Staff OT Manufacturing Engineer to design, validate, and support OT solutions that ensure safe, compliant manufacturing operations.

You will lead PLC/HMI/SCADA, OT–IT integration, cybersecurity, and regulatory validation (IQ/OQ/PQ) across cross-functional teams, traveling to sites as needed.

This role emphasizes robust control systems, data integrity, and continuous improvement in a regulated medical device environment.

Qualifications

• Minimum 8 years manufacturing engineering experience with 3–5 years hands-on OT/control systems in regulated environments.
• Proven leader of OT projects across the full lifecycle: requirements, architecture, development, validation, and post ramp sustainment.
• Advanced PLC/HMI/SCADA proficiency across major platforms and IEC 61131 languages.
• OT–IT integration experience: MES/ERP/PLM interfaces, recipe/batch management, historians.
• OT security and networking skills per IEC 62443 and NIST guidance.
• Experience with regulatory-grade system validation and 21 CFR Part 11 awareness.
• Strong vendor/integrator management and FAT/SAT oversight.
• Excellent written and verbal communication; cross-functional collaboration skills.
• Willingness to travel to manufacturing sites.

Responsibilities

• Design, develop, program, and deploy industrial control systems (PLCs, PACs) and HMI/SCADA for manufacturing.
• Lead OT implementations: define requirements, manage vendors, and provide on-site commissioning and training.
• Plan IQ/OQ/PQ validation for control systems and MES/SCADA integrations; ensure regulatory documentation.
• Integrate OT with MES/ERP/PLM; support data migration and ensure data integrity.
• Implement and maintain secure OT networks; lead cyber risk management per IEC 62443/NIST.
• Troubleshoot production control issues and perform root-cause analysis to improve stability.
• Develop control system documentation: narratives, wiring diagrams, SOPs, validation records.
• Lead risk assessments (pFMEA) and translate findings into mitigations and design changes.
• Collaborate with IT, Quality, Production, and Regulatory to drive improvements.
• Travel to manufacturing sites as required.

Skills

OT systems

Cross-functional leadership

Regulatory compliance

Troubleshooting

Vendor management

Education

Bachelor’s in Electrical/Controls/Automation/Mechatronics/Computer/Mechanical Engineering

Master’s degree preferred

Tools

Rockwell PLC

Siemens PLC

Schneider

Ignition

FactoryTalk

Wonderware

OSIsoft PI

Job description

Johnson & Johnson Innovation is seeking a Staff OT Manufacturing Engineer to design, validate, and support OT solutions that ensure safe, compliant manufacturing operations.

You will lead PLC/HMI/SCADA, OT–IT integration, cybersecurity, and regulatory validation (IQ/OQ/PQ) across cross-functional teams, traveling to sites as needed.

This role emphasizes robust control systems, data integrity, and continuous improvement in a regulated medical device environment.