CSV Engineer

Role Overview

Join one of Ireland's top 10 best companies to work for as a CSV Engineer on a 12-month contract based in Dublin. This position offers an exceptional opportunity to be involved in a large-scale, €1 billion cutting-edge facility project, allowing you to expand your skill set and work with innovative technology within a dynamic environment.

Key Responsibilities

• Design and implement validation protocols such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for computer systems and software applications.
• Work collaboratively with teams from IT, Quality Assurance, and Operations departments to ensure adherence to regulatory standards and internal compliance policies.
• Conduct risk assessments and impact analyses to determine critical system features and potential vulnerabilities.
• Develop and upkeep comprehensive validation documents including validation plans, test scripts, traceability matrices, and summary reports.

Required Qualifications and Experience

• Bachelor's degree in Computer Science, Engineering, or related discipline.
• In-depth understanding of regulatory standards such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
• Proven experience in computer system validation within regulated sectors, ideally pharmaceuticals or biotechnology.
• Knowledge of validation strategies, especially risk-based validation methods.