Overview
CSV System Validation Jobs in Bucharest, Romania at Eurotechsol
Title: CSV System Validation
Company: Eurotechsol
Location: Bucharest, Romania
We are looking for experienced Computerized System Validation (CSV) Consultants to support global Life Sciences projects.
📍 Locations: Poland, Romania & Spain
🏠 Work Mode: Remote / Hybrid
📅 Project Duration: 2+ Years
Key Responsibilities
✅ Execute the complete CSV lifecycle (Validation Planning, URS, FRS, IQ, OQ, PQ, Validation Summary)
✅ Prepare and review validation documentation (Validation Plans, Test Scripts, RTM, Reports)
✅ Perform risk assessments and define validation strategies aligned with GAMP 5 and Computer Software Assurance (CSA)
✅ Support system implementations, upgrades, and change control validation
✅ Ensure compliance with GxP, FDA 21 CFR Part 11, and EU Annex 11
✅ Collaborate with Business, IT, QA, and vendor teams across global locations
✅ Support audits, inspections, deviation management, and CAPA activities
Required Skills
✔ Strong experience in the CSV lifecycle and SDLC
✔ Hands-on experience with URS, FRS, DS, IQ/OQ/PQ, RTM, and validation documentation
✔ Good understanding of GxP, GAMP 5, CSA, and regulatory compliance
✔ Experience with HP ALM, JIRA, Veeva Vault, ServiceNow, or similar tools
✔ Strong analytical, documentation, and communication skills
✔ Experience working with global teams and US/European clients
📩 Interested? Please share your updated CV with your availability, expected rate/salary, and current location.
