CSV Validation Engineer

NovintiX is seeking an experienced OT-IT Integration & Migration Engineer to support OT-to-IT integration and migration efforts across regulated manufacturing environments. The role focuses on identifying impacted OT systems, ensuring validation compliance (IQ/CSV), and executing structured migration plans to enable seamless transition to new IT infrastructure in MedTech operations., * Identify OT systems and their dependencies on IT applications, networks, cloud platforms, and data systems.

• Document system interactions, data flows, and OT-IT integration points.
• Develop and execute migration readiness and transition plans for affected OT systems.
• Ensure compliance with Installation Qualification (IQ), Computer System Validation (CSV), and site validation requirements.
• Coordinate cross-functional, asset management, and change control processes.
• Engage OT/IoT and Operations teams to support migration activities.
• Execute migration readiness and transition plans in collaboration with site OT and IT Subject Matter Experts.
• Coordinate and raise required changes through:
• PLM system (for equipment/process changes)
• IT asset/change management systems (for infrastructure changes)
• Identify and escalate risks, constraints, and dependencies.
• Provide regular status updates to business and technical stakeholders.
• Track progress, issues, and mitigation plans.

• Experience with OT/IT integration, migration, and infrastructure in regulated manufacturing environments.
• Strong understanding of manufacturing networking, cloud, and data systems.
• Familiarity with regulated environment requirements: Equipment Qualification (IQ), Computer System Validation (CSV).
• Understanding of how OT, engineering, IT, and quality teams interact in a MedTech/pharma setup.
• Ability to document system interactions, data flows, and integration points clearly.
• Strong coordination and stakeholder communication skills., * 8-12 years of experience in Computer Science, Information Technology, Biotechnology, Pharmacy, or Biomedical Engineering.
• Prior experience in medical device or other regulated industry is preferred.
• Familiarity with PLM and IT asset/change management systems is preferred.
• Knowledge of MES, PLCs, and manufacturing automation system migration is preferred. If Interested apply at rupa.raja@novintix.com

4.64.6 out of 5 stars Warsaw, IN 46582 $29.40 - $35.41 an hour - Contract