Wai Phone Tint Email & Phone Number

Waltham, Ma, Us

Hatboro, Pennsylvania, Us

Validation Consultant Projects: Sanofi (Framingham, MA)• Executed the validation and commissioning of GMP equipment in the Manufacturing Facility. • Authored and executed IQ/OQ/PQ protocols• Authored Life Cycle Documents (Functional Risk Assessment, GxP impact assessment, Risk Classification, User Requirement Specifications)• Authored Change Controls, CAPAs, and Deviations• Operated GE Kaye Validator 2000, Lives, Ellabs for data collection and report generation• Assisted in root cause analysis for validation deviations• Executed Freezers (-80C, -20C, -40C), Walk-In Cold Rooms (-20C), Refrigerators (5C), Cryogenic Freezers, Controlled Rate Freezers, Sartorius Waves Bioreactors, NucleoCounter (NC-200), Clean Room Facility Qualification (Installation and Operational Qualification, Design Qualification), Siemens Blood Gas Analyzers, Welders, Sealers, Process Gases (Installation and Operational Qualification), Environmental Qualification, Decommissioning Qualification (Clean Room Facility), Backed up and Restore Qualification on Computerized Equipment, Filling Station and Cryo-pods, and Miltenyi Biotec Prodigy

Richfield, Minnesota, Us

Temperature Mapping Projects: Replimune (Framingham, MA), New England BioLabs (Ipswich, MA), Elevate Bio (Waltham, MA), Siemens (Norwood, MA), Takeda (Cambridge, MA), Masy BioServices (Pepperell, MA)• Authored and executed (IOPQ temperature mapping protocols on Ultra Low Freezers, Refrigerators, Walk-in Cold Rooms, Walk-In Freezers, Incubators, Warehouses, Controlled Rate Freezers, Cryogenic Freezers, Humidity Walk-in Rooms, Humidity CTUs. • Operated Kaye, DataTrace Wireless, SenseAnywhere wireless sensors for warehouses

Manchester, Nh, Us

• Executed test procedures on a medical device according to written procedures and documented test results.• Contributed to design failure investigations and root-cause analysis for a medical device,• Cooperating with Engineering personnel to assist with troubleshooting as needed.

Lawrence, Massachusetts, Us

• Assisted with phases of projects, to resolve advanced and complex technical problems.• Participated in design and development of new medical equipment, and upgrades to existing products.• Participated in conceptual design discussions, design reviews, and design verification testing.• Contributed to design failure investigations and root-cause analysis.• Troubleshot mechanical or electrical problems to ensure requirements were met and recommended specific improvements. • Assisted senior engineers in developing new processes for testing medical devices and writing test procedures. • Executed product testing plans to verify new product designs.

Lowell, Ma, Us

As a Student Ambassador, I presented campus life to the new international students, guided them to different department buildings, classes, and Laboratories. Assisted and Organized ISSO events for all students such as Thanksgiving dinner, Mall trips, and etc.Assisted Interviewing to new Student Ambassadors.

I was instructed from the basic of "How to maintain an aircraft." The engineers who are working there show and perform their role in maintaining aircraft. As a Mechanical engineering student, i was looking and following steps that an Mechanical engineer dissemble the body parts of the engine and taught me topics on Hydraulics, non - explosive testing and explosive testing.