Staff OT Manufacturing Engineer- Shockwave

Biopharma Careers; Santa Clara (CA); On-site; USD 109,000 - 175,000; Full time

Benefits offered by this job

Vacation 120 hours/year

Sick time 40 hours/year (state-based)

Parental Leave

401(k) plan

Job summary

Johnson & Johnson is seeking a Staff OT Manufacturing Engineer to design, implement, validate, and support OT solutions that enable safe and compliant manufacturing. Focus areas include PLC/SCADA/DCS, MES interfaces, and validation across the full lifecycle.

The role requires 8+ years in manufacturing engineering with hands-on OT in regulated environments, strong PLC/HMI/SCADA experience, and expertise in OT–IT integration and cybersecurity within GMP contexts.

Qualifications

• Bachelor’s degree in Electrical/Controls/Automation/Mechatronics/Computer/Mechanical Engineering; Master’s preferred.
• Minimum 8 years’ manufacturing engineering experience, including 3–5 years hands on OT/control systems in regulated environments (medical device/pharma preferred).
• Proven leader of OT projects across full lifecycle: requirements, architecture, PLC/HMI/SCADA development, vendor selection, commissioning, IQ/OQ/PQ validation, and post ramp sustainment.
• Advanced PLC/HMI/SCADA proficiency across major platforms and IEC 61131 languages (Ladder, Structured Text, Function Block).
• OT–IT integration expertise: MES/ERP/PLM interfaces, ISA 95, recipe/batch management, historians, real time alarms/events, and OT S/OE reporting.
• OT security and industrial networking skills: segmentation, switches/VLANs, firewalls, secure access, patch management, IEC 62443/NIST.
• Experience with regulatory system validation (IQ/OQ/PQ) and 21 CFR Part 11 concepts for electronic records.
• Strong troubleshooting, vendor/integrator management, and cross-functional leadership.

Responsibilities

• Design, develop, deploy and validate industrial control systems (PLCs, PACs) and HMI/SCADA applications to support manufacturing.
• Lead OT implementations: define requirements, manage vendors, and provide on-site commissioning and ramp support.
• Plan and execute IQ/OQ/PQ validation for control systems and MES/SCADA integrations; ensure regulatory documentation.
• Integrate OT with MES/ERP/PLM interfaces and support data migration and electronic records integrity.
• Maintain secure OT networks; lead cyber risk management and incident response per IEC 62443/NIST.
• Troubleshoot production control issues; conduct root cause analysis and implement corrective actions.
• Develop control system documentation and validation artifacts; lead risk assessments (pFMEA) and mitigation actions.
• Travel to manufacturing sites as required.

Skills

OT project leadership

PLC/HMI/SCADA

IEC 61131 languages

MES/ERP integration

OT security

Regulatory validation

Vendor management

Cross-functional teamwork

Education

Bachelors in Electrical/Controls/Automation

Master's preferred

Tools

Rockwell

Siemens

Schneider

Ignition

FactoryTalk

Wonderware

Job description

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 MedTech, 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. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function

Supply Chain Engineering

Job Sub Function

Manufacturing Engineering

Job Category

Scientific/Technology

All Job Posting Locations

Santa Clara, California, United States of America

Job Description

Position Overview

The Staff Operational Technology (OT) Manufacturing Engineer is responsible for designing, implementing, validating, and supporting operational technology solutions that enable safe, compliant, and efficient manufacturing operations. This role focuses on industrial control systems, automation, OT–IT integration, and lifecycle support of PLC/SCADA/DCS systems and MES interfaces for on‑market products. The Staff OT Engineer partners with R&D, Quality, Production, IT, and Supply Chain to ensure robust control systems, validated processes, and secure, reliable production operations.

Essential Job Functions

• Design, develop, program, and deploy industrial control systems (PLCs, PACs), HMI/SCADA applications, and control logic to support manufacturing processes.
• Lead OT for process/tool/fixture implementations: define functional/user requirements and system specifications, manage vendor deliverables, and provide on‑site commissioning, ramp support, and operator/maintainer training.
• Plan and execute system validation activities (IQ/OQ/PQ) for control systems, sequencing logic, and MES/SCADA integrations; ensure documentation meets regulatory requirements.
• Integrate OT systems with MES/ERP/PLM systems (data handshakes, batch records, recipe management), support data migration and ensure electronic records integrity.
• Implement and maintain secure, segmented OT networks with IT/cybersecurity; lead OT cyber risk management (vulnerabilities, patching/compensating controls, access controls, incident response) aligned to IEC 62443 and NIST.
• Troubleshoot production control issues, perform root cause analysis (DMAIC), and implement corrective actions to restore and improve process stability and throughput.
• Develop and maintain control system documentation: control logic descriptions, wiring diagrams, I/O lists, HMI screen specs, SOPs, and validation records.
• Lead or participate in pFMEA and risk assessments focused on control and automation risks; translate risk findings into mitigation actions and design changes.
• Conduct capability studies and process monitoring where OT systems provide process control data (Cpk analyses, SPC implementations).
• Manage vendor relationships for control system components, PLC/HMI platforms, and system integrators; review and accept vendor deliverables.
• Participate in continuous improvement projects to increase automation reliability, reduce downtime, and support scalability.
• Other duties as assigned. These job requirements are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel.

Requirements

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

Preferred Qualifications

• Certifications: IEC 62443 practitioner/certification, GICSP, ISA, vendor‑specific PLC/HMI certifications, or relevant OT security credentials.
• Formal project management certification (PMP) or equivalent demonstrated multi‑project leadership experience.
• Experience with implementation of historians (e.g., OSIsoft PI)
• Experience designing and implementing architecture for SCADA or an OT communication layer, that delivers centralization of IOT data and supports cloud‑based OT analytics platforms.
• Prior experience in medical device or pharmaceutical manufacturing with direct support for audits and regulatory submissions.
• Six Sigma or Lean certification and experience applying statistical methods (Cpk, SPC) using Minitab or similar tools to OT‑sourced process data.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ([e-mail]) or contact AskGS to be directed to your accommodation resource.

Required Skills

• Accelerating, Coaching, Compliance Risk, Critical Thinking, Facility Management, Good Manufacturing Practices (GMP), Lean Manufacturing Principles, Lean Supply Chain Management, Manufacturing Engineering, Performance Measurement, Product Design, Program Management, Project Engineering, Project Schedule, Robotic Automation, Safety-Oriented, Science, Technology, Engineering, and Math (STEM) Application, Technologically Savvy

Preferred Skills

• Accelerating, Coaching, Compliance Risk, Critical Thinking, Facility Management, Good Manufacturing Practices (GMP), Lean Manufacturing Principles, Lean Supply Chain Management, Manufacturing Engineering, Performance Measurement, Product Design, Program Management, Project Engineering, Project Schedule, Robotic Automation, Safety-Oriented, Science, Technology, Engineering, and Math (STEM) Application, Technologically Savvy

The anticipated base pay range for this position is

$109,000.00 - $174,800.00

Additional Description for Pay Transparency

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Company’s long-term incentive program.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits