Rajendra Sah
@rajendrasah
CSV engineer specializing in Veeva Vault validation, GxP compliance, and ALCOA+ data integrity.
United StatesWhat I'm looking for
I’m a Computer System Validation (CSV) Engineer with 5+ years of experience in GxP-regulated pharma environments. I lead validation lifecycle work end-to-end, from URS through IQ/OQ/PQ and RTM, with a strong focus on audit readiness.
I specialize in Veeva Vault (QualityDocs/eTMF) and have validated other systems including LIMS and SAP in line with GAMP5, 21 CFR Part 11, Annex 11, and cGMP expectations. I apply data integrity and audit trail verification using ALCOA+ principles, and I author and manage validation documentation such as URS, FRS, IQ/OQ/PQ, RTM, and Validation Reports.
I also bring secure access control experience—validating RBAC and access controls and integrating secure credential management and session monitoring using CyberArk/IAM. I collaborate closely with QA, IT, and business stakeholders, manage deviations, and support regulatory audits with zero critical findings.
Experience
Work history, roles, and key accomplishments
Executed end-to-end CSV activities (URS, IQ/OQ/PQ, RTM) for GxP-regulated systems, including validation of Veeva Vault (QualityDocs/eTMF). Performed GAMP 5-aligned risk assessments, data integrity (ALCOA+) and audit trail verification, and collaborated with QA/IT/business stakeholders to validate RBAC, credentials management, and session monitoring.
Validated GxP systems including Veeva Vault, LIMS, and SAP by executing protocols, managing deviations, and performing risk-based and periodic reviews. Authored URS/FRS/IQ/OQ/PQ/RTM and validation reports, conducted audit trail and electronic signature validation, and supported regulatory audits with zero critical findings.
Supported IQ/OQ/PQ execution and helped create validation documentation aligned to GAMP 5 standards. Participated in testing activities, defect tracking, and documentation workflows to maintain audit readiness and Part 11-aligned electronic signature compliance.
Education
Degrees, certifications, and relevant coursework
Hood College
Master of Science in Information Technology, Information Technology
Earned a Master of Science in Information Technology at Hood College.
Tech stack
Software and tools used professionally
Availability
Location
United StatesAuthorized to work in
Job categories
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