Senior OT Cybersecurity & CRA Compliance Architect

Title: Senior OT Cybersecurity & CRA Compliance Architect Location: Bedford, MA (Hybrid) - 3 Days/Week Duration: 12 months (possibility of extension) VISA : on W2

Role Summary

We are seeking an experienced OT Cybersecurity Architect to lead cybersecurity, cyber resilience, and regulatory compliance initiatives in a GMP-regulated pharmaceutical environment. The role focuses on Rockwell PLC (ControlLogix/CompactLogix) systems, Ignition SCADA, and compliance with EU Cyber Resilience Act (CRA), IEC 62443/ISA99, ISA 95, GMP, and FDA 21 CFR Part 11.

Key Responsibilities

• Lead CRA implementation and gap assessments for OT systems.
• Define and maintain global OT reference architecture (Purdue model, zones & conduits, DMZ).
• Secure and harden Rockwell PLCs and Ignition SCADA environments.
• Perform OT cyber risk assessments and threat modelling.
• Implement secure configuration baselines for servers and engineering workstations.
• Ensure compliance with GMP & FDA 21 CFR Part 11 (audit trails, electronic records, RBAC).
• Support Computer System Validation (CSV) documentation (URS/NFR/FS/DS/IQ/OQ/PQ).
• Define patch management and vulnerability handling processes for validated OT systems.
• Support audit readiness and regulatory inspections.