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The consultant will work closely with global stakeholders to establish secure OT environments and ... Ensure OT systems align with IEC 62443 / ISA99, ISA-95, GMP, FDA 21 CFR Part 11, and other ...

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Consultant - OT Cybersecurity Architect | Life Sciences

2T Consulting

Charlestown, MA

Full-time

Posted 2 days ago

New


Job description

We are seeking an experienced OT Cybersecurity Architect to lead cybersecurity, cyber resilience, and regulatory compliance initiatives within a GMP-regulated pharmaceutical environment.

The ideal candidate will have strong expertise in Operational Technology (OT) cybersecurity architecture , industrial control systems, regulatory compliance, and risk management. The consultant will work closely with global stakeholders to establish secure OT environments and ensure compliance with applicable cybersecurity and pharmaceutical industry standards.

Key Responsibilities
  • Lead EU Cyber Resilience Act (CRA) implementation activities and perform cybersecurity gap assessments for OT systems.
  • Define, develop, and maintain a global OT cybersecurity reference architecture.
  • Design and implement cybersecurity strategies for industrial control systems and OT environments.
  • Assess and strengthen cyber resilience across manufacturing and automation environments.
  • Work extensively with Rockwell PLC ControlLogix and CompactLogix systems.
  • Support cybersecurity architecture and controls for Ignition SCADA environments.
  • Ensure OT systems align with IEC 62443 / ISA99, ISA-95, GMP, FDA 21 CFR Part 11, and other applicable regulatory requirements.
  • Conduct security assessments, identify gaps, and develop remediation strategies.
  • Collaborate with engineering, automation, IT, cybersecurity, quality, compliance, and business stakeholders.
  • Translate regulatory and cybersecurity requirements into practical OT security controls and architecture.
  • Provide technical leadership and guidance throughout cybersecurity initiatives.
  • Ensure project deliverables are completed on time with zero schedule slippages.
  • Document architecture, security requirements, assessments, risks, and remediation plans.
Required Qualifications
  • 8–10+ years of experience in cybersecurity, OT security, industrial automation security, or related fields.
  • Bachelor's or Master's degree in Engineering or a related technical discipline.
  • Strong experience in OT/ICS cybersecurity architecture.
  • Hands-on knowledge of Rockwell ControlLogix and CompactLogix PLC systems.
  • Experience with Ignition SCADA.
  • Strong understanding of IEC 62443 / ISA99 and ISA-95.
  • Experience working in GMP-regulated pharmaceutical or life sciences environments.
  • Knowledge of FDA 21 CFR Part 11 requirements.
  • Experience with cybersecurity compliance assessments and gap analysis.
  • Understanding of the EU Cyber Resilience Act (CRA) and its impact on OT/industrial systems.
  • Strong communication, stakeholder management, and collaboration skills.
  • Demonstrated ability to independently manage responsibilities and deliver projects within strict timelines.