Summary
Overview
Work History
Education
Skills
Timeline
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Himanth Paruchuri

Bridgewater Corners,VT

Summary

Detail-oriented Computer System Validation (CSV) Engineer with 6+ years of experience in validating laboratory and enterprise systems within GxP-regulated environments. Proven track record in LabWare LIMS, Empower, Chromeleon, TrackWise, and SAP ERP system validations. Hands-on expertise in software lifecycle management (SDLC), GAMP 5 methodologies, and 21 CFR Part 11 compliance. Adept at writing validation documentation, conducting risk assessments, and leading IT service support (Tier-3) for lab-based applications.

Experienced with applying engineering principles to real-world problems, leading to impactful solutions. Utilizes analytical skills and technical knowledge to enhance operational efficiency. Track record of effective team collaboration and project completion.

Overview

8
8
years of professional experience

Work History

CSV Engineer

Kyowa Kirin
05.2021 - Current
  • Led validation of LabWare LIMS and GxP desktop/web applications by creating and executing IQ/OQ/PQ protocols and ensuring traceability.
  • Developed and reviewed URS, FRS, system design specifications, and validation test scripts aligned with 21 CFR Part 11 and GAMP 5.
  • Administered and supported laboratory software systems including Empower, Chromeleon, and LIMS, performing Tier-3 support and ticket resolution.
  • Configured system workflows and participated in user provisioning via Active Directory and Office 365 Admin Console.
  • Conducted audit trail reviews and periodic system assessments, authored SOPs for system usage, data backup, recovery, and testing procedures.
  • Participated in CSV project lifecycle, including planning, validation, implementation, change control, and system retirement.

CSV Engineer

Circle Pharma
11.2018 - 05.2021
  • Executed validation of lab instrumentation and software including Empower CDS, Chromeleon, LabX, and HPLC, ensuring strict adherence to GxP and 21 CFR Part 11 standards.
  • Authored and maintained Installation and Operational Qualification (IQ/OQ) protocols, SOPs, and system configuration documents.
  • Performed data integrity assessments and compliance audits for various instruments: UPLC, GC, Particle Counters, and UV-Vis Spectrophotometers.
  • Decommissioned legacy systems (e.g., EZ Chrom), executing data migration and change control procedures.
  • Validated Watson LIMS and supported manual testing phases including UAT and regression testing.

Validation Engineer

Kite Pharma
07.2017 - 11.2018
  • Implemented and validated LabWare LIMS for R&D and QC labs, including integration with supporting lab equipment.
  • Authored validation documentation: Validation Plan, URS, FRS, Traceability Matrix, Summary Reports, and supported system testing phases.
  • Performed GxP risk and impact assessments, supported deviation management, and ensured compliance with Data Integrity policies.
  • Worked with QA and IT teams to ensure system configurations met business and compliance requirements.
  • Reviewed SOPs and enforced compliance through CAPA management and change control processes.

Education

Master of Science - Information Systems

Central Michigan University
Mount Pleasant, MI
05-2023

Bachelor of Science - Mechanical Engineering

SreeNidhi Institute Of Science And Technology
Hyderabad, India
08-2016

Skills

  • Validation Tools: IQ/OQ/PQ Protocols, Trace Matrices, Risk Assessments, Test Plans
  • Systems Validated: LabWare LIMS, LabX, Chromeleon, Empower, SAP, TrackWise, ChemStation
  • Compliance: 21 CFR Part 11, GAMP 5, Annex 11, Data Integrity (ALCOA), FDA, MHRA
  • Software & OS: Windows Server, Active Directory, Microsoft Office 365, Exchange
  • Testing: Manual Testing, Regression Testing, Functional Testing, UAT
  • Documentation: URS, FRS, VMP, Validation Summary Reports, SOPs
  • DevOps Knowledge: Change Control, CAPA, Deviation Management
  • Tools: Jira, ServiceNow, SharePoint, LIMS Admin Tools
  • Critical thinking
  • Project management
  • Project planning
  • Data analysis
  • Engineering documentation
  • System troubleshooting
  • Root-cause analysis
  • Time management
  • Quality control
  • Quality assurance controls
  • Technical writing
  • Process improvement
  • Software development
  • Programming languages
  • Manufacturing processes

Timeline

CSV Engineer

Kyowa Kirin
05.2021 - Current

CSV Engineer

Circle Pharma
11.2018 - 05.2021

Validation Engineer

Kite Pharma
07.2017 - 11.2018

Master of Science - Information Systems

Central Michigan University

Bachelor of Science - Mechanical Engineering

SreeNidhi Institute Of Science And Technology

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