CSV Automation Engineer - Ireland, Dublin - 12 Month Contract
Are you a CSV Automation Engineer looking for your next challenge in Dublin? A leading multinational in Ireland’s thriving biopharma industry is expanding their team for a major facility development.
This project provides hands‑on experience with innovative equipment, large‑scale operations, and modern pharmaceutical technologies. It’s an ideal opportunity to build your skills within one of Europe’s fastest‑growing life‑science regions.
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.
Conduct periodic reviews to ensure ongoing compliance with regulatory requirements and internal procedures.
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.
Proficiency in creating and executing validation protocols and documenting validation activities.
Be part of something bigger. Start your application today!
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