Senior OT Cybersecurity & CRA Compliance Architect

Job Description

We are looking for a Senior OT Cybersecurity & CRA Compliance Architect with extensive experience securing Operational Technology (OT) environments within the pharmaceutical or life sciences industry. The ideal candidate will have deep expertise in EU Cyber Resilience Act (CRA), IEC 62443/ISA99, GMP compliance, FDA 21 CFR Part 11, and industrial automation platforms including Rockwell ControlLogix/CompactLogix PLCs and Ignition SCADA.

Key Responsibilities

• Lead EU Cyber Resilience Act (CRA) implementation, assessments, and remediation activities.
• Design and maintain OT security architecture using the Purdue Model, Zones & Conduits, and Industrial DMZ.
• Secure and harden Rockwell PLC and Ignition SCADA environments.
• Perform OT cybersecurity risk assessments, threat modeling, and vulnerability analysis.
• Develop secure configuration baselines for OT servers, engineering workstations, and industrial assets.
• Ensure compliance with GMP regulations and FDA 21 CFR Part 11, including audit trails, electronic records, and role-based access control (RBAC).
• Support Computer System Validation (CSV) documentation including URS, FS, DS, IQ, OQ, PQ, and NFR.
• Define patch management and vulnerability remediation processes for validated OT systems.
• Support cybersecurity audits, regulatory inspections, and compliance initiatives.

Required Skills

• 10+ years of experience in OT/Industrial Cybersecurity.
• Strong expertise in EU Cyber Resilience Act (CRA) implementation.
• Hands-on experience with Rockwell ControlLogix/CompactLogix PLCs.
• Experience securing Ignition SCADA environments.
• Deep knowledge of IEC 62443 / ISA99, ISA-95, and Purdue Architecture.
• Experience with GMP, FDA 21 CFR Part 11, and Computer System Validation (CSV).
• Strong understanding of OT network segmentation, Industrial DMZ, vulnerability management, and secure architecture.
• Excellent communication and stakeholder management skills.

Preferred Industry Experience

• Pharmaceutical
• Life Sciences
• Biotechnology
• Manufacturing with GMP-regulated environments

If you are interested or know someone who would be a great fit, please share your updated resume along with your contact details and work authorization.