CSV Engineer - Ireland, Dublin - 12 Month Contract One of the top 10 best companies to work in Ireland is looking for CSV Engineer for their large-scale new facility in Dublin.
Is this you?An exciting project there is lots of opportunity to learn new technology and develop current skills within a fast paced €1 billion project.
This fantastic client offers the opportunity to work within a large-scale environment with cutting edge technology.
What You'll Do Develop and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for computer systems and software applications.
Collaborate with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure compliance with regulatory guidelines and internal policies.
Perform risk assessments and impact analyses to identify critical system functionalities and potential vulnerabilities.
Create and maintain validation documentation, such as validation plans, test scripts, traceability matrices, and validation summary reports.
What you'll need: Bachelor's degree in Computer Science, Engineering, or a related field.
Strong knowledge of regulatory guidelines, such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
Extensive experience in computer system validation within a regulated industry, preferably pharmaceuticals or biotechnology.
Familiarity with validation methodologies, including risk-based validation approaches.
If this role is of interest, please apply now