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직무 설명
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.