CSV Engineer

About the role

The CSV Engineer will lead the planning, execution and continuous improvement of Computer System Validation (CSV) activities for GxP‑related computerized systems. Working independently, you will ensure that all systems remain compliant with regulatory expectations and are audit‑ready.

Key responsibilities

• Prepare, execute and report validation deliverables for GxP computerized systems.
• Verify that all validation work complies with FDA, EMA and internal standards.
• Maintain the validated state of systems through periodic reviews and remediation.
• Manage end‑to‑end project implementation, track progress and handle escalations.
• Support self‑inspection, audit readiness and remediation activities.
• Update and develop CSV procedures, standards and the system inventory.
• Handle QMS activities such as Change Controls, Deviations, Investigations and CAPAs.
• Review protocols, QMS documentation and CSV deliverables for accuracy.
• Provide CSV training to cross‑functional team members.

Required profile

• In‑depth knowledge of regulatory requirements for GxP computerized systems (21 CFR Part 11, EU Annex 11, GAMP 5).
• Proven ability to deliver and sustain CSV compliance in a regulated environment.
• Strong organizational, analytical and problem‑solving capabilities.
• Ability to work autonomously and guide others when needed.

Required skills

• 21 CFR Part 11
• EU Annex 11
• GAMP 5
• Quality Management System (QMS) processes