Tushar Patil
Principal Process Engineer @Kindeva Drug Delivery
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WORK HISTORY
Principal Process Engineer @Kindeva Drug Delivery
Northridge, CA, US
Acted as SME for packaging and assembly lines, ensuring equipment ownership, validated state (AQM), and compliance with cGMP and site safety standards.• Installed and validated a new automated assembly line with 10 packaging machines, executing URS, FAT, SAT, IQ, OQ, and PQ; optimized process parameters via DOE. Delivered new automated line with zero major deviations.• Increased line capacity by 43%(7M → 10M units/year) by alleviating bottlenecks with new Bander machine, casepacker throughput improvements, and Kaizen initiatives. Reduced downtime by 26% through sensor upgrades.• Upgraded legacy equipment with modern sensors (fiber optic, UV, distance) and automation enhancements, reducing downtime and improving reliability.• Developed Power BI troubleshooting guides to standardize root cause identification and accelerate operator response.• Partnered with Quality and Operations to lead investigations, CAPA, and change control processes; authored/approved technical reports, validation protocols, and deviations.• Mentored engineers and line staff on troubleshooting, validation, and scientific problem-solving approaches, fostering knowledge-sharing and compliance.• Supported site in inspection readiness, contributing to audits with no critical findings in packaging operations.
EDUCATION
Vishwakarma Institute Of Technology
Bachelor of Engineering (BE), Mechanical Engineering
California State University-Sacramento
Master of Science (M.S.), Mechanical Engineering
SKILLS
ABOUT TUSHAR PATIL
Summary: BSME, MSME, ASQ-CQE with 15 years of experience in pharmaceutical and medical device manufacturing. Recognized SME in packaging and process engineering with expertise in cGMP, ISO 13485, FDA/EU MDR, and OSHA. Proven leader in equipment installation, qualification (IQ/OQ/PQ), process optimization, and regulatory inspection readiness. Skilled in DOE, SPC, CAPA, and root cause analysis, driving efficiency, and reliability.• Specialties: Process Validation, Lean manufacturing, Six sigma, Product Development, Solidworks, Team Center, Design and Optimization, Finite Element Analysis, MATLAB, Minitab, AutoCAD, Pro-Engineer Creo 5, CATIA, Simewise 4D.
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