Validation Engineer
Caguas, Pr, Pr
•Develop validation master plans, process flow diagrams, test cases, and standard operating procedures.•Working in multiples projects, one of them finishing 2 months before expected in this project I validated an Alloy sealing machine with PLC, Solid Works and Mini tab for statistical analysis.•Software validation for Test Lab (Sealing Validation Equipment) in Progress using Infinity QS program, Microsoft project to monitor timeline, as Project Management coordinate meetings and follow up with It and Technicians works.•Develop project to have a spare Alloy sealing Machine for a product, create all documentation from ECR and validation plan, execute and reports for closing the validation. •Prepare and develop project of double sealing validation for Fluids unit to re used blisters when rework its needed, also this reduce scrap, that cost money. Creating project timeline, and validation documentation using Microsoft project and Microsoft word.•Packaging and execution knowledge of tests in New Product and Operations products.•Prepare and maintain, validation and compliance documentation, such as engineering change notices, schematics, and protocols.•Assist in training equipment operators and other staff on validation protocols and standard operating procedures.•Conduct validation and qualification tests of new or existing processes, equipment, and software in accordance with internal protocols and external standards.•Coordinate the implementation and scheduling of validation testing with affected departments and personnel.•Create, populate, or maintain databases for tracking validation activities, test results, or validated systems.•Prepare detailed reports or design statements, based on results of validation and qualification tests and reviews of procedures and protocols.•Direct validation activities, such as protocol creation and testing.