Summary
Overview
Work History
Education
Skills
Timeline
Generic

Your Name

Summary

IT professional with over 7 years of experience in Pharmaceutical and IT/Services industry as a Validation engineer. Experience of working in regulated environments within pharmaceutical, clinical, and life science industries. Thorough understanding of Computer System Validation, GMP, GLP practices, 21 CFR part11, laboratory workflows and end to end validation process. Acquired working experience in startups as well as large company environment in Quality Assurance and Software Testing experience on Web-Based Applications using Agile, V-Model and Waterfall Methodologies. Experienced in implementation and enhancement projects within the guidelines of the Project Life Cycle and Software Development Life Cycle (SDLC). Extensive experience in authoring business and validation deliverables such as Validation master plan, User Requirement Specification (URS), Functional Requirement Specification (FRS), Business Requirement Document (BRD). Expert in testing documentation of Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ). Skilled at authoring Validation reports, Test Strategy, Requirement Risk Assessment. Experience is designing use case diagrams, process flow diagrams Excellent in interpersonal, written and verbal skills. Ability to multi-task, prioritize and manage increasingly complex issues. Expertise in manual testing and test automation of Web applications. Knowledge on Selenium Components: Selenium WebDriver, Selenium GRID and Selenium IDE. Experience in creating Data Driven test automation framework with Selenium Web Driver/IDE (Java), JUnit. Developed Java based library to read test data from XML & Properties files using JUnit and Selenium. Coordinated with the development team and other stakeholders in resolving crucial bugs. Facilitated meeting with upper management to provide status and achievements of the project Self-Starter with excellent analytical, problem solving, communication skills

Overview

10
10
years of professional experience

Work History

CSV Validation Engineer

Altice Usa
02.2023 - Current
  • Authored and reviewed technical documents such as Configuration Specification, Design Qualification Summary, Initial Engineering Extend Assessment (EEA) and Validation Extend Assessment (VEA) in Valgenesis
  • Author Admin SOP in Veeva Vault.
  • Created business applications and user roles in Service Now
  • Experience writing Data Integrity Risk Assessment (DIRA)
  • System experience Includes: MALDI TOF, HIAC PharmSpec, and Genetic Analyzer

CSV Validation Engineer

Gilead
09.2022 - 04.2023
  • Documented entire validation process, noting changes or alterations completed.
  • Generated and executed Test Scripts based on Requirements and validation plans for LIMS projects.
  • Collaborated with developers and project managers to assess program capabilities, features and testing demands.
  • Proposed development and testing improvements to positively impact usability, function and performance.
  • Completed tests under tight deadlines to meet client demands and project timelines.
  • Produced and maintained consistent technical documentation using Veeva Qulaity Docs and Valgenesis.

CSV Validation Engineer

Xrevol | Palo Alto
01.2020 - 09.2022
  • Documented entire validation process, noting changes or alterations completed.
  • Collaborated with developers and project managers to assess program capabilities, features and testing demands.
  • Core understanding of ALM, including import of requirements, Test Scripts, Approval and Traceability of Req and Test Script in ALM for multiple projects.
  • Proposed development and testing improvements to positively impact usability, function and performance.
  • Completed projects under tight deadlines to meet client demands and project timelines.
  • Led risk assessment meetings, offering input on assessments such as system impact, component criticality, data integrity and other factors.
  • Generated validation plans for projects, setting specific temporal goals for development and delivery.
  • Produced all validation deliverables and work closely with business and QA in review and approvals.
  • Developed and executed Test Scripts for core system testing, reports testing and User acceptance testing.

Validation Engineer/Business Analyst

Company Name
02.2016 - 12.2019
  • Meet business contacts to collect and analyze business requirements as part of a Change Control implementation
  • Work primarily with LabWare LIMS (v6), SQL, Crystal Reports, and HP ALM
  • End-to-End Validation activities include creating a validation Plan, Change Control, Test Strategy, Quality Risk Assessment, Requirement Specification, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
  • Authoring and reviewing business requirement specifications (URS), functional requirement specifications (FRS), Design Specification (DS) and Requirement Risk Assessment
  • Performed validation activities for various LIMS Quarterly and new enhancement releases
  • Authorized IQ, OQ, PQ, traceability matrix, discrepancy forms and validation summary reports
  • Dry Run and formal validation execution of IQ, OQ, PQ Test protocol
  • Authored change control details in Track wise system for implementing the enhancements to the LIMS application
  • Involved in the LIMS Stability Management module implementation to the new sites
  • Performed the validation activities for the LIMS low risk maintenance items
  • Managed all the GxP documents in Veeva
  • Worked on the Labware LIMS Analytical and CoA Reports
  • Reviewed and modified existing Standard Operating Systems (SOPs) and authored the work Instructions (WI), Forms
  • Analyzed existing processes and systems to identify the gaps and opportunities for improvement
  • Extensively involved in resolving bug fixing with Development Team
  • Coordinated User acceptance Testing (UAT) and gathered requirements, which involved Stakeholders, Business Leads and Validation Team
  • Proposed improvements to development and testing processes to positively impact usability, function and performance
  • Managed Veeva Vault integration enhancements with Visual Workflow in LabWare LIMS (Laboratory Information Management System)

Business Analyst

Company Name
11.2014 - 10.2015
  • Created test plans and test specifications based on Product Requirement Analysis Documents and Functional Requirement Documents (FRD)
  • Review business requirement documents and analyze the business requirements
  • Developed the test plan, test strategy and review with pears
  • Perform manual and automated testing of a web-based application
  • Key expertise includes testing and debugging GUI and Multi-Applications environment and automated testing using Selenium WebDriver
  • Write test case in test driven approach with mock object and well define interfaces
  • Created user defined functions to enhance the maintainability of scripts
  • Developed test code in Java language using Eclipse IDE
  • Automated web application using Selenium-Web Driver and Java
  • Reported bugs using Asana
  • Performed GUI testing, functionality testing according to requirement specification documents
  • Hands on experience using Selenium RC and writing Selenium tests through Eclipse/Selenium IDE

Education

Bachelor of Science - Electronics and Communications Engineering

Anna University

Skills

  • Labware LIMS V6 (Laboratory Information Management System)- With knowledge of Master Data, Stability, Lot and EM workflows
  • Track wise, LES, ELN
  • Veeva Vault
  • Bug Tracking Tools
  • Microsoft Excel, JIRA, Asana
  • Testing tools
  • ALM
  • ValGenesis
  • Success Factors
  • Service Now
  • Project /Document Management Tools
  • SharePoint
  • SQL
  • Microsoft Office
  • MS Word, Excel, PowerPoint, Visio
  • System Documentation
  • Validation test Scripts, Work Instruction,
  • Others

Timeline

CSV Validation Engineer

Altice Usa
02.2023 - Current

CSV Validation Engineer

Gilead
09.2022 - 04.2023

CSV Validation Engineer

Xrevol | Palo Alto
01.2020 - 09.2022

Validation Engineer/Business Analyst

Company Name
02.2016 - 12.2019

Business Analyst

Company Name
11.2014 - 10.2015

Bachelor of Science - Electronics and Communications Engineering

Anna University