Title: 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 (ControLogix/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.

Required Skills & Expertise

OT & Automation

Rockwell ControlLogix / CompactLogix
Studio 5000
EtherNet/IP
Ignition SCADA configuration & security
OPC / Industrial protocols

Cybersecurity

IEC 62443 implementation
Network segmentation & firewall design
Secure remote access architecture
Vulnerability & patch management (OT context)
Threat modeling & risk assessment

Regulatory & Compliance

EU Cyber Resilience Act (CRA)
GMP (Pharma manufacturing systems)
FDA 21 CFR Part 11
Computer Svstem Validation (CSV)

Change control in regulated environments
System Hardening

Windows Server hardening (SCADA, Historian,
Engineering Stations)
Active Directory design and security for OT domains
CIS benchmarks & security baseline implementation
Group Policy (GPO) hardening and privilege management
Application listing (e.g., AppLocker)
Secure service configuration & port minimization
Local admin restriction & credential protection
Secure RDP configuration & jump server model
Patch validation in GMP-regulated environments
Backup integrity verification & disaster recovery validation
Log configuration, retention & audit trail protection

Experience Required

8+ years in OT / ICS cybersecurity
3+ years in Pharma or regulated industry
Hands-on experience with Rockwell PLC and Ignition

SCADA

Experience implementing IEC 62443 controls

Preferred Certifications

IEC 62443 Cybersecurity Expert
GICSP / CISSP
Rockwell Automation certifications

Senior OT Cybersecurity & CRA Compliance Architect

Quick Overview

Job Description

Skills

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