GxP CSV Engineer — Validation & Lifecycle Expert

Orise; Blanchardstown; Vor Ort; EUR 65.000 - 95.000; Vollzeit

Zusammenfassung

Orise is seeking a CSV Engineer to collaborate with project teams on GxP Computerised Systems CSV activities across multiple projects. The role focuses on defining CSV strategy with clients and preparing validation protocols and associated documentation.

The successful candidate will manage CSV activities, support system operations through periodic reviews and change controls, and contribute to continual improvement of processes while maintaining strong client relationships.

Qualifikationen

• Bachelor’s degree in Computer Science or related field or 5 years’ relevant experience.
• Minimum 3 years CSV experience in the Life Sciences sector.
• Detailed knowledge of regulatory guidance documents and standards.

Aufgaben

• Manage CSV activities and client relationships.
• Define CSV strategy with client project teams.
• Prepare and test validation protocols and documentation for GxP CS.
• Support operation of systems with Periodic Reviews, Change Controls and Audit Trail Reviews.
• Assist with generation of CSV related documentation.
• Act as Process Champion to improve internal processes.

Kenntnisse

CSV compliance

Client communication

Project teamwork

Self-starter

Ausbildung

BSc in CS/CE

Regulatory knowledge

Jobbeschreibung

Orise is seeking a CSV Engineer to collaborate with project teams on GxP Computerised Systems CSV activities across multiple projects. The role focuses on defining CSV strategy with clients and preparing validation protocols and associated documentation.

The successful candidate will manage CSV activities, support system operations through periodic reviews and change controls, and contribute to continual improvement of processes while maintaining strong client relationships.