CSV Engineer: GxP Validation Lead for Life Sciences

Orise

Dublin

Hybrid

EUR 60,000 - 80,000

Full time

4 days ago

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Job summary

Orise is seeking a CSV professional to manage client CSV activities and define validation strategies within project teams. You will prepare and test validation protocols and related documentation for GxP Computerised Systems, supporting Periodic Reviews, Change Controls and Audit Trail Reviews.

The role requires excellent communication, the ability to explain IT/Validation concepts to teams, and a proactive, organized approach.

Qualifications

Bachelor’s degree in CS/CE or related field or 5 years relevant experience.
3+ years CSV experience in Life Sciences.

Responsibilities

Manage client CSV activities and relationships.
Define CSV strategy with client project teams.
Prepare and test validation protocols and documentation for GxP Computerised Systems.
Support operation of systems by executing Periodic Reviews, Change Controls and Audit Trail Reviews.
Provide assistance with generation of CSV documentation and act as process champion to improve internal processes.
Develop and maintain client site expertise to enhance Orise-client relationships.
Contribute to GxP Computerised Systems lifecycle documents across validation lifecycle for all asset types.
Review/Approval of GxP Validation Documentation.
Administer GAMP lifecycle across concurrent projects.
Any other duties as assigned.