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 and CFR Part , 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 .

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/...