Vaishnavi G.
Senior Equipment Validation Engineer • San Diego, CA • v**************@gmail.com • 732****818 • linkedin.com/••••• • drivetube.ai/•••••
Professional Summary
Senior Validation Engineer with 6+ years of experience delivering equipment, process and computer system validation across medical device, pharmaceutical and automotive manufacturing. Deep expertise authoring and executing IQ/OQ/PQ, TMV and requalification protocols for automated assembly, injection molding and ultrasonic welding systems and in validating laboratory test equipment. Experienced in Computer System Validation (URS, functional specs, UAT) and maintaining traceability in Jama, JIRA and DOORS to meet 21 CFR Part 11 and GAMP 5. Applied SPC, Cp/Cpk, MSA and Gage R&R to establish operating windows and sampling plans. Led DVP&R activities for automotive subsystems and closed 20+ CAPAs tied to validation findings, partnering closely with QA, Manufacturing and R&D to support design transfer and regulatory readiness.
Technical Skills
Programming Language: Python,LabVIEW,R
Testing & QA: ISO 13485,ISO 14971,Automated Test Fixtures,IQ,OQ,PQ,Ultrasonic Welders,Environmental Chambers
Supply Chain Management: Cpk
ERP & Supply Chain Systems: SAP
Project Management & Collaboration: Jama,Jira,DOORS,Kneat
Clinical Standards & Compliance: FDA 21 CFR Part 11
Quality Assurance & Compliance: cGMP
Validation & Qualification: Method Validation,Computer System Validation,Factory Acceptance Testing,FAT,Site Acceptance Testing,SAT,Requalification
Manufacturing & Quality: MSA,Injection Molding
Industrial Systems & Automation: PLC
Materials & Mechanical Analysis: Data Acquisition
Work Experience
ResMed
San Diego, CA
Senior Equipment Validation Engineer
Nov 2025 – Present
Medical device manufacturer for respiratory products; supported equipment and laboratory validation for production and verification testing.
Tech Stack: Injection Molding Machines, Ultrasonic Welders, Environmental Chambers, Data Acquisition Systems, Jama, JIRA
- Authored and executed IQ, OQ and PQ protocols for 15+ automated assembly systems including injection molding machines and ultrasonic welders to verify functionality and acceptance criteria for respiratory device lines.
- Developed and executed Test Method Validation and equipment requalification protocols to maintain process capability across material lots and production shifts, documenting sampling plans and acceptance criteria.
- Coordinated Factory Acceptance Testing and Site Acceptance Testing by reviewing URS and FAT/SAT evidence to confirm equipment design conformance prior to installation.
- Performed cleanroom qualification and environmental monitoring to verify HVAC and particulate controls met ISO 14644 classifications and facility requirements.
- Investigated and resolved process deviations identified during protocol execution using 8D and Ishikawa analyses and implemented corrective actions to restore validated state.
- Managed CAPA and change control for equipment and process modifications, closing 20+ CAPAs tied to validation nonconformances to sustain validated production.
- Validated environmental chambers using data acquisition systems to verify test conditions and recorded test outcomes for verification activities.
- Maintained requirements traceability matrices and supported User Acceptance Testing in Jama and JIRA to link URS to validation deliverables.
AbbVie
North Chicago, IL
Quality & Validation Engineer
Jan 2024 – Oct 2025
Pharmaceutical manufacturing and analytical laboratories; delivered equipment, cleaning and computerized system validation to meet cGMP requirements.
Tech Stack: DOORS
- Authored, executed and approved IQ/OQ/PQ protocols for pharmaceutical manufacturing equipment and utilities to ensure cGMP compliance for production and laboratory systems.
- Led cleaning validation studies for process equipment, producing sampling plans and acceptance criteria to demonstrate effective residue removal.
- Performed Computer System Validation activities including URS, functional/design specifications and UAT for GxP applications to ensure data integrity and 21 CFR Part 11 compliance.
- Maintained requirements traceability matrices linking user requirements to test protocols and validation deliverables in DOORS and TrackWise.
- Investigated deviations and out-of-specification events using 5 Why and DMAIC methodologies to define root cause and corrective actions.
- Managed CAPA initiatives related to validation and quality nonconformances, closing 25+ CAPAs and documenting effectiveness of corrective actions.
- Backed internal and external regulatory audits by preparing validation documentation and technical justification demonstrating adherence to ISO 13485, ISO 14971 and cGMP.
Aurobindo Pharma
India
Validation Analyst / Tester
June 2022 – Aug 2023
Pharmaceutical manufacturing operations supporting cleaning validation, CIP/SIP and technology transfer validation activities under cGMP.
Tech Stack: Kneat, SAP
- Authored cleaning validation protocols and executed studies using Kneat paperless validation system to capture sampling plans and acceptance criteria.
- Executed IQ/OQ/PQ protocols including sampling, data collection and documentation for equipment and process validation studies and prepared project closeout reports.
- Backed discrepancy investigations, punch list resolution and retesting activities to address protocol deviations and meet project timelines.
- Partnered with Quality Assurance and subject matter experts to review and approve validation deliverables in compliance with cGMP.
- Managed change control records in SAP for equipment replacement and process upgrades, assessing revalidation scope and requirements.
- Supported risk assessment activities to identify validation requirements for new and modified manufacturing processes and CIP/SIP systems during technology transfer.
Tata Motors
India
Validation Engineer
July 2020 – May 2022
Automotive engineering and subsystem validation; delivered DVP&R and automated test solutions for electrical and mechanical subsystems.
Tech Stack: Python, LabVIEW, Automated Test Fixtures
- Led validation of 12 automotive subsystems, authoring DVP&R documentation to ensure traceability from requirements to test results.
- Programmed test automation scripts in Python and LabVIEW for automated test fixtures to streamline data acquisition and reduce manual test effort.
- Configured data acquisition hardware and PLC-controlled test systems and interpreted electrical and pneumatic schematics to troubleshoot test issues.
- Analyzed test data using MSA and Gage R&R to assess measurement system capability and documented findings in validation reports.
- Developed laboratory test plans and executed torque and vision system inspections to validate subsystem performance against design requirements.
- Performed root cause analysis on test failures and recommended corrective actions to improve design robustness and assembly yield.
Education
Malla Reddy Institute of Technology
Bachelor of Technology, Computer Science and Engineering • India • 2016 – 2020
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