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CSV Engineer
hays-gcj-v4-pd-onlineDublin North30+ days ago
Job descriptionBachelor'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. 5+ Years 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 Excellent analytical and problem-solving skills, with attention to detail.
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
- 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 to succeed
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Engineer Engineer • Dublin North