Hima Yellapragada

Computer System Validation Engineer @ Clinvira Inc

About

I’m a Computer System Validation (CSV) Engineer with over 6 years of experience supporting pharmaceutical, biotech, and medical device companies in achieving GxP compliance and maintaining data integrity across regulated environments. I specialize in implementing risk-based validation strategies aligned with 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines. My experience spans validation of LIMS, MES, TrackWise, Empower, SAP, and other enterprise systems, with strong expertise in authoring and executing VMPs, URS/FRS/DS, IQ/OQ/PQ, and RTMs. I leverage Python, SQL, and PowerShell to automate validation testing, streamline data verification, and support cloud validation initiatives on AWS and Azure platforms. I’m passionate about driving compliance through digital transformation, paperless validation systems, and effective collaboration across QA, IT, and manufacturing teams to ensure inspection readiness and continuous improvement in validation practices.

Country

United States

City

Kansas

Industry

Information Technology & Services

Skill

Verification and Validation (V&V), QMS, TrackWise, MES, Software as a Service (SaaS), FDA / EMA, Amazon Web Services (AWS), Azure DevOps, SQL for Data Verification, Python, TrackWise QMS, LIMS, Validation Lifecycle Management, Validation Master Plan (VMP), Auditing, ALCOA+, GAMP 5, EU Annex 11, GxP Compliance, Computerized System Validation (CSV)

Experience

Computer System Validation Engineer

Clinvira Inc

2023-9 - Present · 3 yrs 1 mo

●Led enterprise-scale Computer System Validation (CSV) programs for ERP, MES, and LIMS platforms across multiple manufacturing and QC sites under GxP control. ●Conducted data integrity assessments and implemented audit trail review procedures aligned with ALCOA+ and regulatory expectations. ●Managed change control, CAPA, and periodic reviews, ensuring systems remained compliant and validated post-deployment. ●Collaborated with QA, IT, and infrastructure teams to qualify on-prem and cloud environments (AWS, Azure) per GAMP 5 Category 4/5 standards.

CSV Specialist

KONNECTSU TECHNOLOGIES PVT. LTD

2019-4 - 2023-5 · 4 yrs 2 mos

●Authored and reviewed URS, FRS/DS, RTM, IQ/OQ/PQ, and VSR deliverables ensuring full traceability and compliance with 21 CFR Part 11 / EU Annex 11. ●Validated system interfaces and data integrations across LIMS, MES, SAP, and QMS, maintaining accuracy and end-to-end process integrity. ●Conducted vendor and supplier audits, reviewing FAT/SAT packages to qualify third-party systems against internal GxP standards. ●Participated in SIT and UAT execution, preparing validation evidence and supporting FDA/EMA audit readiness through documented traceability.