Senior CSV Engineer - GxP Validation Lead

Orise; Blanchardstown; On-site; EUR 55,000 - 85,000; Full time

Job summary

Orise is seeking a CSV Engineer to collaborate with project teams on GxP Computerised Systems CSV activities across multiple projects in Ireland. You will manage client CSV activities, define strategies with teams, and prepare validation protocols with associated documentation.

You will support periodic reviews, change controls and audit trail reviews, producing CSV documentation and acting as a process champion to continuously improve internal processes and client interactions.

Qualifications

• Bachelor’s degree in a relevant field or 5 years of CSV experience.
• A minimum of 3 years CSV experience in the Life Sciences sector.
• Detailed knowledge of regulatory guidance documents and standards.

Responsibilities

• Manage CSV activities and client relationships.
• Work with project teams to define CSV strategy for projects.
• Prepare and test validation protocols and related documentation for GxP CS.
• Support Periodic Reviews, Change Controls and Audit Trail Reviews.
• Assist in generating CSV-related documentation.
• Act as Process Champion to improve internal processes.
• Develop and maintain client site expertise to enhance Orise relationships.
• Contribute to GxP CS lifecycle documents across validation lifecycle for various assets.
• Review/approve all GxP CS Validation Documentation.
• Administer GAMP lifecycle across concurrent projects.
• Perform other duties as assigned.
• Communicate IT/Validation concepts effectively to teams.
• Be organized and adapt to fast-paced environments.
• Interact well within customer environments.
• Strong knowledge of Quality Management System processes (change control, CAPA, deviation).

Skills

GxP CS

Client relationship management

Excellent communication

Self-starter

Education

Bachelor’s degree in Computer Science/Computer Engineering/Computer Information Systems or related field

5 years relevant CSV experience

Job description

Orise is seeking a CSV Engineer to collaborate with project teams on GxP Computerised Systems CSV activities across multiple projects in Ireland. You will manage client CSV activities, define strategies with teams, and prepare validation protocols with associated documentation.

You will support periodic reviews, change controls and audit trail reviews, producing CSV documentation and acting as a process champion to continuously improve internal processes and client interactions.