Staff OT Manufacturing Engineer- Shockwave

Johnson & Johnson Innovative Medicine•Santa Clara, CA

2d•$109,000 - $174,800

About The Position

The Staff Operational Technology (OT) Manufacturing Engineer designs, implements, validates, and supports operational technology solutions for safe, compliant, and efficient manufacturing. The position focuses on industrial control systems, automation, OT–IT integration, and lifecycle support for PLC, SCADA, DCS, and MES interfaces supporting on-market products. The engineer partners with R&D, Quality, Production, IT, and Supply Chain to ensure reliable control systems, validated processes, and secure production operations. The role leads OT implementations for processes, tools, and fixtures, from requirements and specifications through vendor management, commissioning, ramp support, and training. It also supports system validation, manufacturing-system integration, OT network security, production troubleshooting, risk assessment, capability studies, documentation, and continuous improvement.

Requirements

Bachelor’s degree in Electrical, Controls, Automation, Mechatronics, Computer, or Mechanical Engineering.
At least 8 years of manufacturing engineering experience, including 3–5 years of hands-on OT/control-systems experience in regulated environments; medical device or pharmaceutical experience is preferred.
Experience leading OT projects through the full lifecycle, including requirements, architecture, PLC/HMI/SCADA development, vendor selection, commissioning, IQ/OQ/PQ validation, and post-ramp sustainment.
Advanced proficiency with major PLC/HMI/SCADA platforms such as Rockwell, Siemens, Schneider, Ignition, FactoryTalk, or Wonderware, and fluency in IEC 61131-3 languages such as Ladder, Structured Text, and Function Block.
OT–IT integration expertise, including MES/ERP/PLM interfaces, ISA-95, recipe and batch management, historians, real-time alarms/events, and OT-sourced OEE/Cpk reporting.
OT security and industrial networking skills, including network segmentation, managed switches/VLANs, industrial firewalls, secure remote/vendor access, vulnerability and patch management, and familiarity with IEC 62443 and NIST guidance.
Experience with regulated system validation and documentation, including IQ/OQ/PQ, validation plans and protocols, trace matrices, and deviation handling; awareness of 21 CFR Part 11 concepts.
Strong troubleshooting and root-cause skills for PLC logic, HMI behavior, communication faults, and on-site commissioning diagnostics.
Strong vendor and integrator management skills, including scoping, technical acceptance, FAT/SAT oversight, and contract deliverable governance.
Ability to lead cross-functional teams, mentor junior OT/control engineers, and influence IT, Quality, Production, and Regulatory stakeholders.
Excellent written and verbal communication skills, including experience producing technical specifications, control narratives, validation artifacts, SOPs, and executive summaries.
Willingness and ability to travel to manufacturing sites as required.

Nice To Haves

Master’s degree.
IEC 62443 practitioner/certification, GICSP, ISA, vendor-specific PLC/HMI certifications, or relevant OT security credentials.
PMP certification or equivalent demonstrated multi-project leadership experience.
Experience implementing historians such as OSIsoft PI.
Experience designing and implementing SCADA or OT communication-layer architecture that centralizes IoT data and supports cloud-based OT analytics platforms.
Medical device or pharmaceutical manufacturing experience, including direct support for audits and regulatory submissions.
Six Sigma or Lean certification and experience applying statistical methods such as Cpk and SPC to OT-sourced process data using Minitab or similar tools.

Responsibilities

Design, develop, program, and deploy PLCs, PACs, HMI/SCADA applications, and control logic for manufacturing processes.
Lead OT implementation for processes, tools, and fixtures, including requirements, specifications, vendor deliverables, commissioning, ramp support, and operator and maintainer training.
Plan and execute IQ/OQ/PQ validation for control systems, sequencing logic, and MES/SCADA integrations, ensuring documentation meets regulatory requirements.
Integrate OT systems with MES, ERP, and PLM systems; support data migration and ensure electronic-record integrity.
Implement and maintain secure, segmented OT networks with IT and cybersecurity partners, and lead OT cyber risk management.
Troubleshoot production control issues, conduct root cause analysis, and implement corrective actions to improve process stability and throughput.
Develop and maintain control-system documentation, including logic descriptions, wiring diagrams, I/O lists, HMI specifications, SOPs, and validation records.
Lead or participate in pFMEA and risk assessments for control and automation, and implement resulting mitigations and design changes.
Conduct capability studies and process monitoring using OT process-control data, including Cpk analyses and SPC implementations.
Manage control-system, PLC/HMI platform, and system-integrator vendors; review and accept vendor deliverables.
Participate in continuous-improvement projects to increase automation reliability, reduce downtime, and support scalability.
Perform other duties as assigned.