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). Implementation Partner:
Infosys. End Client:
To be disclosed (Pharama).

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 (Control Logix/Compact Logix) systems,
Ignition SCADA
, and compliance with EU Cyber Resilience Act (CRA),
IEC 62443/ISA
99
, ISA 95
, GMP
, and FDA 21 CFR Part 11
.

• 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.