Staff OT Manufacturing Engineer- Shockwave

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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 OTIT integration and lifecycle support of PLC/SCADA/DCS systems and MES interfaces for onmarket 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 onsite 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

• Bachelors in Electrical/Controls/Automation/Mechatronics/Computer/Mechanical Engineering. Masters preferred.
• Minimum 8 years manufacturing engineering experience including 35 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).
• OTIT 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 crossfunctional 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 vendorspecific PLC/HMI certifications or relevant OT security credentials.
• Formal project management certification (PMP) or equivalent demonstrated multiproject 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 cloudbased 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 OTsourced 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 () or contact AskGS to be directed to your accommodation resource.

Required Skills:

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 :

$109000.00 - $174800.00

Additional Description for Pay Transparency:

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

This position is eligible to participate in the Companys long-term incentive program.

Subject to the terms of their respective policies and date of hire employees are eligible for the following time off 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: - Experience:

Staff IC