IT Compliance Engineer

Job Summary

IT Compliance Engineer - The IT Compliance Engineer ensures that IT infrastructure applications and data systems in a life science manufacturing environment meet GxP 21 CFR Part 11 EU Annex 11 and data integrity requirements. The role supports qualification validation and lifecycle control of systems manages audit readiness and partners with IT QA and Operations to maintain a secure compliant and inspection-ready state.

Responsibilities

• Perform infrastructure qualification (servers networks virtualization cloud) and support CSV activities per GAMP 5 for GxP applications
• Ensure IT systems comply with 21 CFR Part 11 EU Annex 11 and data integrity (ALCOA+) principles
• Develop review and maintain IT SOPs policies and validation documentation covering backup security access management and disaster recovery
• Manage change control deviations CAPAs and impact assessments for IT systems to maintain a validated state
• Conduct periodic reviews access reviews audit trail reviews and system risk assessments
• Support internal audits customer audits and regulatory inspections including preparing evidence and responding to findings
• Evaluate and qualify vendors cloud providers and service partners for GxP suitability and quality agreements
• Partner with Cybersecurity to align IT controls with compliance requirements (e.g. user access patching vulnerability management OT/IT segmentation)
• Monitor compliance metrics identify gaps and drive remediation and continuous improvement initiatives
• Provide compliance guidance and training to IT teams system owners and project teams on GxP and data integrity expectations