Jignesh Patel

About Jignesh Patel

5+ years of wide-ranging experience in Cleaning Validation & Equipment Validation Engineering in Pharmaceutical in accordance with 21 CFR Part 11, 21 CFR Part 4, and 21 CFR Part 820 and other GXP (GMP, GCP, GLP) regulations and Good Documentation Practices (GDP) · Strong experience in commissioning, qualification, and validation of equipment like FTIR, HPLC, TOC Analyzer, Microplate Readers, Plate washers, Lyophilized, Autoclaves, Incubators, Skids, Process Tanks, CIP Tanks, Bioreactors, Refrigerators, and Freezers.· Validation Engineer with Process, Facility, Equipment, Cleaning, and computerized system Validation experience in an Aseptic Bio-pharmaceutical manufacturing environment. Generated and executed IQ, OQ, PQ, and PV protocols, testing procedures, SOPs document, change control, and generation of final reports. Conducted system testing. · Expertise in the use of equipment like TOC analyzer and HPLC system for the analysis of Swab and Rinse samples of equipment and analysis of USP water.· Validation Engineer with Process, Facility, Equipment, Cleaning, and computerized system Validation experience in an Aseptic Bio-pharmaceutical manufacturing environment. Generated and executed IQ, OQ, PQ, and PV protocols, testing procedures, SOP documents, change controls, and the generation of final reports. Conducted system testing· Experience in authoring and reviewing Validation Master Plans, Standard Operating Procedures (SOP), and Validation Summary Reports.· Experience in cleaning Work-in-Progress (WIP) Tanks, Tank cleaning, cleaning of Product Transfer Line Piping Systems, cleaning of High-Volume Filling Systems, cleaning cycle development, cleaning validation, sanitization validation, swab and rinse sampling collection techniques, thermal sanitization, chemical sanitization, and troubleshooting cleaning issues· Experience with unit operations like mixing, cleaning, filter sterilization, autoclave, SIP, and VHP (Vaporized Hydrogen Peroxide) decontamination.· Knowledge of various types of testing such as Performance testing, Positive testing, Negative testing, and User Acceptance testing (UAT) using manual and automated tools and good knowledge of cGMP, GCP, and GLP validation practices.· Experience in the cleaning of Work-in-Progress (WIP) Tanks, Tank cleaning, cleaning of Product Transfer Line Piping Systems, cleaning of High-Volume Filling Systems, cleaning cycle development, cleaning validation, sanitization validation, swab and rinse sampling collection techniques, thermal sanitization, chemical sanitization, and troubleshooting.

Experience

1. Sr Validation Engineer

   Amneal Pharmaceuticals

   Jan 2023 — Present · Fort Washington, PA, US

   Conducted clean-in-place (CIP), clean-out place (COP), Sterilization in place (SIP), and manual cleaning validation activities.· Developed and executed cleaning validation protocols for manufacturing and process equipment like Rotary Mills, Bin Blenders, and Tablet DE dusters with Integrated Metal Detectors, Tablet Presses, Filling Machines, Fluid Beds, High Shear Granulators, Capsule Polishers, Tablet Film Coaters.· Conducted clean-in-place (CIP), clean-out place (COP), Sterilization in place (SIP), and manual cleaning validation activities.· Supported cleaning validation studies by working with cross-functional teams including product development, quality control, and internal data auditors.· Perform cleaning validation/verification studies using the rinse method, swab sampling, and visual inspection method for the parts washer and vessels.· Conducted full cleaning verification and cleaning validation studies including spray ball coverage/riboflavin test, cycle development, Dirty hold time, and clean hold time verification for upstream and downstream equipment · Supported cleaning validation studies by working with cross-functional teams including product development, quality control, and internal data auditors.· Responsible for CIP/COP and manual cleaning validation activities, troubleshooting CIP system failures, optimizing CIP/COP systems including manual processes and CIP equipment, and developing SIP/CIP/COP Cycles. · Implemented remediation tasks (FDA Warning Letter, Internal CAPA) covering Gap Assessment, URS & Validation Master Plan, Equipment and Process Parameters (Centrifuges, Chromatography Columns, Aseptic Filtration, Fume Hoods), Engineering & Optimization Studies, IQ/OQ/PQ/PV Protocol generation & execution, Final Reports for Equipment, Facilities, Clean Utilities, Process & Cleaning Validation, the inclusion of Regulated Assets for Final Product and Reagent Anti-Body Coating Process.

Education

• Trine University

  Master's degree

  2013 — 2015