CSV Engineer

CSV Engineer - Ireland, Dublin - 12 Month Contract

One of the top 10 best companies to work in Ireland is looking for a 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!
#LI-JS4