Sravan Kumar
Milwaukee,WI
Summary
Computer System Validation (CSV) professional with 4+ years of experience supporting GxP-regulated pharmaceutical and life sciences environments, specializing in risk-based validation aligned with FDA 21 CFR Part 11, GAMP 5, and ALCOA+ data integrity principles. Experienced in authoring and executing validation deliverables including URS, FRS, DS, IQ/OQ/PQ, RTM, and validation reports across the SDLC lifecycle. Proficient in validating enterprise and laboratory systems such as LIMS, Veeva Vault, SAP, MES, ServiceNow, and TrackWise, while collaborating with QA, IT, and cross-functional teams to maintain compliance, ensure system reliability, and support audit readiness.
Overview
5
5
years of professional experience
Work History
CVS Engineer
Client #1
10.2024 - Current
- Managed end-to-end computer system validation (CSV) for GxP regulated systems, focusing on LIMS, Veeva Vault, SAP, and MES to uphold regulatory standards.
- Conducted thorough validation processes, encompassing URS, FRS, DS, IQ/OQ/PQ protocols, and detailed reporting to support quality assurance initiatives.
- Conducted thorough risk-based validation assessments to align processes with GAMP5 guidelines and FDA 21 CFR Part 11 requirements.
- Execute functional, integration, system, and regression testing to ensure systems meet intended use.
- Perform data integrity assessments and audit trail reviews in alignment with ALCOA+ principles.
- Manage deviations, CAPA, and change control activities, ensuring validated state is maintained.
- Utilize HP ALM, QTest, and JIRA for test management, traceability, and defect tracking.
- Coordinated efforts with QA, IT, manufacturing, and automation teams, focusing on system implementation and upgrade processes.
CSV Engineer
Client #2
06.2023 - 09.2024
- Executed IQ/OQ/PQ validation activities for laboratory systems, manufacturing applications, and enterprise platforms.
- Validated integrated systems including SAP, MES, and LIMS, ensuring data exchange integrity across platforms.
- Authored and reviewed URS, FRS, RTM, validation protocols, and validation summary reports.
- Performed electronic records and electronic signature validation in compliance with 21 CFR Part 11.
- Conducted audit trail reviews, user access verification, and system security assessments.
- Supported CAPA, deviation investigations, and change control processes to maintain compliance.
- Assisted in risk assessments and periodic reviews for validated systems.
- Worked with cross-functional teams to resolve validation issues and maintain inspection readiness.
CVS Analyst
Client #3
01.2021 - 08.2022
- Supported CSV testing for laboratory systems and analytical instruments including HPLC and chromatography systems.
- Assisted in authoring and executing URS, FRS, DS, IQ/OQ/PQ protocols.
- Developed and maintained Traceability Matrices (RTM) to ensure complete requirement-to-test coverage.
- Executed functional and regression testing for enterprise applications including SAP and ServiceNow.
- Documented test results, exceptions, and deviation reports in accordance with GxP requirements.
- Supported data migration verification and validation documentation reviews.
- Assisted in SOP development and SDLC documentation to support regulatory compliance.
- Collaborated with QA and IT teams to ensure systems remained in a validated and compliant state.
Education
Bachelor of Science -
Anna University
Master of Science -
University of Wisconsin, Milwaukee
Milwaukee, WISkills
- Computer System Validation (CSV)
- FDA 21 CFR Part 11 / 210 / 211 / 820
- IQ / OQ / PQ Execution
- GAMP 5, EU Annex 11
- Risk-Based Validation
- cGMP, GLP, GCP, GDP
- Validation Master Plan (VMP)
- Data Integrity (ALCOA)
- Validation Project Plan (VPP)
- URS, FRS, DS
- LIMS
- RTM (Traceability Matrix)
- Veeva Vault (QMS, Docs)
- Validation Protocols
- SAP ERP
Validation & Compliance
Regulatory Standards
Documentation
Systems & Platforms
- Validation Summary Reports
- MES
- ServiceNow
- HP ALM / Quality Center
- TrackWise
- JIRA
- MODA-ES
- Kneat Gx
- QTest
- Python, Java, C
- SQL
- Windows, Linux
- Selenium (basic)
- MySQL, Oracle, SQL Server
- Git / SVN
Tools
Technical
Operating Systems & Databases
Timeline
CVS Engineer
Client #1
10.2024 - Current
CSV Engineer
Client #2
06.2023 - 09.2024
CVS Analyst
Client #3
01.2021 - 08.2022
Bachelor of Science -
Anna University
Master of Science -
University of Wisconsin, Milwaukee