We are looking for an experienced Technical Architect to lead automation, SCADA, MES integration, and digital transformation initiatives for a leading contact lens manufacturer in a highly regulated medical device manufacturing environment.
- Lead and mentor a team of 15+ onsite and offshore engineers, serving as the primary technical point of contact for customers.
- Architect and deliver shop-floor-to-MES integration solutions aligned with ISA-95 standards.
- Lead legacy system modernization, retrofit activities, and migration of control platforms and SCADA systems.
- Implement and support Ignition SCADA solutions for real-time production KPI monitoring, OEE tracking, throughput, yield, and equipment utilization.
- Design MQTT-based communication frameworks connecting PLCs with enterprise systems.
- Drive IT/OT convergence, predictive analytics, centralized monitoring, and remote diagnostics.
- Develop data pipelines and analytics solutions using Canary and AVEVA Historians.
- Ensure compliance with FDA regulations and 21 CFR Part 11, including electronic records, audit trails, and access controls.
- Support OT cybersecurity initiatives, including DCOM hardening, OPC UA, and AVEVA SiteLink.
- Manage validation documentation, change requests, requirements, design specifications, testing, and operational documentation.
- Support NC/CAPA processes, audit readiness, and compliance requirements in medical device manufacturing.
- Provide technical leadership in SCADA/HMI development, historian configuration, and alarm management.
- SCADA/HMI: Ignition, Wonderware, ArchestrA System Platform
- MES integration and ISA-95 standards
- PLC integration and industrial automation
- MQTT and OPC UA communication protocols
- IT/OT convergence and OT cybersecurity
- Canary and AVEVA Historians
- FDA-regulated manufacturing and 21 CFR Part 11
- System modernization, retrofit, and legacy migration
- Technical architecture, project delivery, and team leadership
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