Staff OT Manufacturing Engineer- Shockwave

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

are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel.

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

• ✓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.

• ✓Certifications: IEC 62443 practitioner/certification, GICSP, ISA, vendor‑specific PLC/HMI certifications,