Your new company
At Hays Specialist Recruitment we have a great opportunity for a CSV Engineer to join our Biopharmaceutical client in Dublin on an initial 20-month contract.The CSV Engineer (Computer System Validation Engineer) is responsible for validating and maintaining computerised systems to meet regulatory requirements and industry best practices.
Your new role
1. Develop and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for computer systems and software applications.
2. Collaborate with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure compliance with regulatory guidelines and internal policies.
3. Perform risk assessments and impact analyses to identify critical system functionalities and potential vulnerabilities.
4. Create and maintain validation documentation, such as validation plans, test scripts, traceability matrices, and validation summary reports.
5. Conduct periodic reviews to ensure ongoing compliance with regulatory requirements and internal procedures.
What you'll need to succeed
6. Bachelor's degree in Computer Science, Engineering, or a related field.
7. Strong knowledge of regulatory guidelines, such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
8. 5+ Years experience in computer system validation within a regulated industry, preferably pharmaceuticals or biotechnology.
9. Familiarity with validation methodologies, including risk-based validation approaches.
10. Proficiency in creating and executing validation protocols and documenting validation activities
11. Excellent analytical and problem-solving skills, with attention to detail.