Senior OT Cybersecurity & CRA Compliance Architect (Pharma – Rockwell / Ignition)
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.
