Sagar Shah
Raritan,NJ
Summary
Results-driven Validation Engineer with extensive experience at Eli Lilly and Pfizer, excelling in compliance and risk management. Proven track record in CAPA implementation and effective communication, achieving 100% on-time approval rates and zero critical audit findings. Skilled in equipment qualification and lean methodologies, enhancing project efficiency and data integrity across GxP-regulated systems.
Overview
4
4
years of professional experience
Work History
Validation Engineer
Eli Lilly
Branchburg Township, NJ
01.2024 - Current
- Led end-to-end validation lifecycle (requirements, risk assessments, IQ/OQ/PQ execution, summary reporting) for 10+ GxP-regulated systems, ensuring full compliance with FDA 21 CFR Part 11, EU Annex 11, and internal CSV SOPs.
- Authored and reviewed 50+ validation deliverables (Validation Plans, Test Scripts, Traceability Matrices, Validation Reports), achieving a 100% on-time approval rate during project execution.
- Reduced audit findings by 30% by proactively updating and remediating legacy validation documents, closing compliance gaps, and ensuring data integrity per ALCOA+ principles.
- Supported 5 regulatory inspections (FDA, MHRA, internal QA), contributing to zero critical observations by maintaining validated system documentation and ensuring inspection readiness.
- Investigated and resolved system deviations through root cause analysis and CAPA implementation, preventing recurrence and improving compliance efficiency.
- Collaborated cross-functionally with QA, IT, Manufacturing, and Global Compliance teams to deliver CSV projects on schedule, resulting in a 20% reduction in project delays.
- Implemented risk-based validation approaches leveraging GAMP 5, improving efficiency and cutting testing execution time by 15% without compromising compliance.
Validation Engineer
Pfizer
Portage, MI
01.2022 - 12.2023
- Executed full validation lifecycle (URS, risk assessment, IQ/OQ/PQ execution, summary reporting) for GxP-regulated laboratory and manufacturing systems, ensuring compliance with FDA 21 CFR Part 11, EU Annex 11, and Pfizer CSV SOPs.
- Authored, reviewed, and approved 75+ validation deliverables (Validation Plans, Test Protocols, Traceability Matrices, Validation Reports), achieving a 98% first-pass approval rate and accelerating project timelines.
- Strengthened data integrity by applying ALCOA+ principles, ensuring accuracy, traceability, and compliance across all validation documentation and quality records.
- Partnered with QA, IT, and system owners to remediate 20+ legacy systems, closing compliance gaps and achieving zero critical audit observations during FDA and MHRA inspections.
- Supported deviation investigations and CAPA implementation, reducing repeat deviations by 25% and improving audit readiness.
- Implemented risk-based validation strategies (GAMP 5) to optimize testing scope, resulting in a 15% reduction in validation cycle time while maintaining regulatory compliance.
- Led cross-functional collaboration with local and global stakeholders, enabling timely delivery of CSV activities for system upgrades and change controls, improving inspection readiness across Pfizer’s global sites.
Quality Engineer
EXEL International
Redondo Beach, CA
03.2021 - 12.2021
- Developed inspection plans based on design specifications, ensuring all critical dimensions and performance criteria were verified throughout the manufacturing process.
- Improved customer satisfaction levels with timely resolution of non-conformance issues and effective corrective actions.
- Performed quality inspections and drafted reports to detail non-conforming material issues.
- Engaged in root cause analysis to uncover fundamental reasons for system failures.
Education
Industrial Engineering
Illinois Institute of Technology
Chicago, IL12.2020
Skills
- Effective communication
- Equipment qualification
- Testing protocols (Kneat and Paper based)
- CAPA management
- Lean Six Sigma
- Project Management
Timeline
Validation Engineer
Eli Lilly
01.2024 - Current
Validation Engineer
Pfizer
01.2022 - 12.2023
Quality Engineer
EXEL International
03.2021 - 12.2021
Industrial Engineering
Illinois Institute of Technology