CSV and Validation Engineer

Job Description :

We are seeking a hands-on CSV and Validation Engineer to validate software used with laboratory instruments and lab informatics platforms. The role owns risk-based validation planning and execution aligned to EMA Annex 11 and 21 CFR Part 11, authors audit-ready documentation, and partners with QA / IT / Lab to transition systems to standardized SOPs.

Responsibilities :

• Plan and execute computer system validation using a risk-based CSA approach aligned to GAMP 5.
• Validate instrument software and lab systems; author URS, FRS, DS, test plans, IQ / OQ / PQ, traceability, and validation summary reports.
• Design and maintain infrastructure and data flow diagrams covering integrations, security, backup / restore, and audit trails.
• Capture business and technical requirements; maintain a bidirectional requirements traceability matrix.
• Execute test cycles, log defects, drive remediation, manage deviations / CAPA, and support inspections.
• Ensure change control, periodic review, training effectiveness, and release readiness for validated systems.
• Collaborate across QA / CSV, IT, and Lab teams; provide clear communication and stakeholder updates.

Requirements :