22 set - Italia
Jobgether
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a CSV Validation Engineer based in Italy.
This is a senior, hands-on validation role supporting complex technology platforms used in pharmaceutical and other GxP-regulated environments.
You will lead risk-based computerized system validation across cloud applications, edge devices, scientific instruments, APIs, databases, and enterprise integrations.
Your work will help ensure regulated systems are fit for intended use, secure, reliable, and supported by complete, inspection-ready evidence.
You will collaborate closely with Engineering, Product, Quality, Operations, suppliers, and customers across the full system lifecycle.
The role combines regulatory expertise with technical investigation, requiring you to understand architectures, data flows, integrations, and system behavior.
You will also help mature validation practices by introducing practical structure, improving traceability, and leveraging modern engineering evidence.
This is an opportunity to make a direct impact in a growing environment where validation is treated as a critical engineering discipline rather than a documentation exercise.
Accountabilities
- Develop and execute risk-based validation strategies for new systems, product features, integrations, infrastructure changes, releases, and customer implementations, defining appropriate scope according to intended use, system complexity, data-integrity risks, and regulatory requirements.
- Create, maintain, and execute comprehensive CSV deliverables, including validation plans, requirements, functional and configuration specifications, risk assessments, test protocols, IQ/OQ/PQ documentation where applicable, traceability matrices, deviation records, and validation summary reports.
- Translate regulatory and business requirements into clear, objective, testable acceptance criteria and ensure requirements, risks, tests, defe
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