GxP IT Compliance Engineer – Part 11 & Data Integrity

Cognizant; Munster; Vor Ort; EUR 70.000 - 110.000; Vollzeit

Zusammenfassung

Cognizant is seeking an IT Compliance Engineer to ensure that IT infrastructure applications and data systems in a life science manufacturing environment meet GxP and data integrity requirements. The role supports qualification, validation lifecycle, and audit readiness in collaboration with IT QA and Operations.

The engineer will partner with Cybersecurity to align IT controls with compliance requirements, drive remediation, and provide training on GxP and data integrity expectations.

Qualifikationen

• IT compliance and data integrity concepts in life science manufacturing.
• Experience with GxP regulatory requirements (GxP, 21 CFR Part 11, EU Annex 11).
• Familiarity with IT qualification, validation lifecycle, and audit readiness.

Aufgaben

• 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 documents covering backups, 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 (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.

Jobbeschreibung

Cognizant is seeking an IT Compliance Engineer to ensure that IT infrastructure applications and data systems in a life science manufacturing environment meet GxP and data integrity requirements. The role supports qualification, validation lifecycle, and audit readiness in collaboration with IT QA and Operations.

The engineer will partner with Cybersecurity to align IT controls with compliance requirements, drive remediation, and provide training on GxP and data integrity expectations.