Senior Technical Writer & CSV Specialist

KISHORI PATIL

Indianapolis, IN +1-317-***-**** ***************@*****.*** No Sponsorship Required PROFILE SUMMARY

Computerized System Validation (CSV) and Documentation Specialist with direct experience executing cGMP and FDA Quality System compliance in life sciences environments. Specialized in managing document lifecycles in Veeva Vault, executing test protocols in Kneat and ALM, and authoring URS, IQ/OQ protocols, and Validation Summary Reports. Proven track record of bridging technical validation, process coordination, and software development life cycle (SDLC) requirements to ensure audit readiness and data integrity.

CORE SKILLS

Validation & Compliance: CSV, GAMP 5, 21 CFR Part 11, cGMP, GxP, Good Documentation Practices (GDP), Data Integrity (DI), SDLC, V-Model, Risk-Based Validation

Validation & Quality Tools: Kneat (Power User), Veeva Vault (EDMS), OpenText ALM Validation Deliverables: IQ/OQ/PQ Protocols, User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Validation Summary Reports (VSR), Requirements Traceability Matrix (RTM), SOPs Process & Execution: Deviation Management, Defect Tracking, Change Control, Root Cause Analysis, Audit Readiness Technical: HTML5, CSS3, JavaScript, Bootstrap, System Debugging PROFESSIONAL EXPERIENCE

Validation Engineer The CREW Corporation USA April 2026 – Present

Execute and review document lifecycle workflows within Veeva Vault (EDMS), managing routing, approvals, and quality checks in strict alignment with 21 CFR Part 11, cGMP, and GxP requirements

Conduct test management and software validation in OpenText ALM, including executing test scripts, logging deviations, defect tracking, and authoring Validation Summary Reports (VSR)

Ensure data integrity across computerized system documentation by auditing electronic signatures, audit trails, and version controls, while coordinating cross-functional reviews between engineering, QA, and operations to streamline protocol approvals Lead Teacher Abacus Early Learning Center USA Jan 2024 – Mar 2026

Maintained accurate classroom records to ensure compliance with institutional and safety standards.

Prepare weekly lesson plans, essential development skills such as fine motor, Gross motor, Mathematics, Listening skills, literacy and languages, Simple science, Creative development.

Make sure every student understands the material completely and give those who need more guidance on individual basis.

Managed supplies, schedules, and reporting procedures, demonstrating strong documentation and organizational control aligned with regulatory compliance principles.

Validation Engineer Innovative Consulting Pvt Ltd USA April 2021 – Oct 2023

Authored and executed Installation Qualification (IQ) and Operational Qualification (OQ) paperless protocols in Kneat for analytical instruments (HPLC, UV-Vis), enforcing adherence to GAMP 5 and 21 CFR Part 11

Translated User Requirement Specifications (URS) into detailed test cases, verified functional performance through comprehensive system testing, and drafted compliant Validation Summary Reports (VSR) and SOPs based on validation outcomes Front End Developer Gosmarrt Infotech Pvt Ltd India April 2019 – Mar 2020

Engineered responsive web interfaces for Banking and Insurance clients (e.g., Simfi), ensuring code compliance with strictly defined functional requirements.

Collaborated with back-end teams to integrate new features, optimizing application performance and reducing page load times by 20% through efficient code structuring.

Front End Developer Pragix Infotech Pvt Ltd India April 2018 – March 2019

Developed cross-browser compatible applications using HTML5 and Bootstrap, translating User Requirement Specifications (URS) into functional technical solutions.

Utilized Chrome DevTools and Lighthouse for rigorous testing and debugging, ensuring accessibility compliance and robust system stability.

CERTIFICATIONS

cGMP: Intro to GMP ( Link )

Pharmacovigilance: Intro to Drug Safety ( Link )

ICH-GCP: Good Clinical Practice ( Link )

EDUCATION

Master of Engineering in Computer Science North Maharashtra University India 2018 Bachelor of Engineering in Information Technology North Maharashtra University India 2016

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