Cork city, Ireland | Posted on 01/06/2026
The CSV Engineer will be responsible for ensuring that computerized systems used within the organization comply with regulatory requirements and internal quality standards.
This role involves developing, writing, and executing Computer System Validation (CSV) protocols, managing documentation, and supporting audits to maintain winkel compliance with Gx P and other applicable regulations.
Key Responsibilities
Develop and author CSV protocols, including Installation_PUSH Qualification (IQ), Operational Qualification (OQ) on Kneat.
Execute validation protocols and document results in accordance with company SOPs and regulatory guidelines via Kneat.
Perform risk assessments and impact analyses for computerized systems.ist Innen
Ensure compliance with FDA, EMA, and GAMP 5 guidelines for system validation.ial
Collaborate with Automation teams, Quality, and business stakeholders to ensure systems meet user requirements and doubling compliance standards.
Maintain validation documentation and ensure traceability throughout the system lifecycle.
Support internal and external audits by providing validation evidence and responding to queries.
Troubleshoot validation issues and propose corrective actions.
Participate in change control processes for validated systems.
Scientist Requirements
Education: Bachelor's degree in Computer Science, Engineering, Life Sciences, or related field.
Experience
Minimum 2+ years in Computer System Validation within a regulated environment (pharmaceutical, biotech, or medical devices preferred).
Hands‑on experience writing and executing validation protocols (IQ/OQ) on Kneat.
Technical Skills
Strong understanding of GAMP 5, 21 CFR Part 11, and Annex 11 compliance requirements.
Familiarity with Delta V, PLC, MES, or other Gx P systems.
Soft Skills
Excellent documentation and communication skills.
Strong attention to detail and ability to work under strict timelines.
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