Détail du poste We are seeking a candidate with expertise in OT cybersecurity architecture to support cybersecurity, cyber resilience, and regulatory compliance initiatives within a GMP-regulated pharmaceutical environment. The scope of services includes systems based on Rockwell PLC (ControlLogix / CompactLogix) and iFIX SCADA, with consideration for applicable regulations and standards including the EU Cyber Resilience Act (CRA), IEC 62443 / ISA99, ISA-95, GMP, and FDA 21 CFR Part 11. Scope of Services The service provider will deliver expertise and recommendations in the following areas: Perform CRA gap assessments for OT systems and propose remediation roadmaps. Provide guidance for the definition and evolution of the OT reference architecture (Purdue model, zones & conduits, DMZ). Assess and recommend security hardening measures for Rockwell PLC and iFIX SCADA environments. Conduct OT cybersecurity risk assessments and threat modeling. Define secure configuration baselines for OT servers and engineering workstations. Provide recommendations to support compliance with GMP and FDA 21 CFR Part 11 (audit trails, electronic records, RBAC). Contribute to Computer System Validation (CSV) documentation (URS, NFR, FS, DS, IQ, OQ, PQ) where cybersecurity requirements are involved. Propose patch management and vulnerability management processes adapted to validated OT environments. Provide expertise and documentation to support audit preparation and regulatory inspections. FR disposant d'une expertise en architecture de cybersécurité OT afin de soutenir les initiatives de cybersécurité, de cyberrésilience et de conformité réglementaire au sein d'un environnement pharmaceutique soumis aux BPF (Bonnes Pratiques de Fabrication). Le périmètre des services couvre les systèmes basés sur Rockwell PLC (ControlLogix / CompactLogix) et iFIX SCADA, en tenant compte des réglementations et normes applicables, notamment le Cyber Resilience Act (CRA) de l'Union européenne, IEC 62443 / I
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