GxP CSV Engineer: Validation & Lifecycle Expert

Orise; Blanchardstown; On-site; EUR 60,000 - 85,000; Full time

Job summary

Orise is seeking a CSV Engineer to work with project teams on GxP Computerised Systems CSV activities across multiple projects in Ireland. The role involves managing CSV activities and relationships with clients, defining CSV strategy, and preparing validation protocols and documentation.

The successful candidate will support periodic reviews, change controls, and audit trail reviews, and help develop lifecycle documents for GxP assets. Strong communication and MS Office skills are essential.

Qualifications

• A Bachelor’s degree in Computer Science, Computer Engineering, Computer Information Systems, or a related field (or 5 years’ relevant experience).
• A minimum of 3 years CSV experience in the Life Sciences sector.
• Detailed knowledge of regulatory guidance documents and standards.

Responsibilities

• Manage client CSV activities and relationships.
• Define CSV strategy for projects with client teams.
• Prepare and test validation protocols and related documentation.
• Support operation of systems via periodic reviews, change controls, and audit trail reviews.
• Assist with generation of CSV documentation.
• Develop and maintain client site expertise to improve relationships.
• Develop GxP lifecycle documents across validation lifecycle.
• Review/approve GxP validation documentation.

Skills

Communication skills

IT/Validation concepts communication

Self-starter

Organizational skills

Client interaction

MS Office proficiency

Education

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

Job description

Orise is seeking a CSV Engineer to work with project teams on GxP Computerised Systems CSV activities across multiple projects in Ireland. The role involves managing CSV activities and relationships with clients, defining CSV strategy, and preparing validation protocols and documentation.

The successful candidate will support periodic reviews, change controls, and audit trail reviews, and help develop lifecycle documents for GxP assets. Strong communication and MS Office skills are essential.