•Validation Process of manufacturing process and equipment for Packaging and Sub-Assembly Line. (Line Master Validation Log, Validation Assessment, Validation Plan, IQ, Software Validation, OQ/PQ, Test Method Validation, Process Verification).•Lead of packaging line implementation in new manufacturing Site. (Coordination of activities, Validations, support with Regulatory deliverables, Equipment/facilities acquisition, support in day to day activities and APQ run).•Lead of capacity increase project, achieving a 65% growth in production line. (Coordination of activities, Equipment acquisition, layout & facilities support, validations, space optimization)•Minitab six sigma (Sixpack) analysis for equipment validation.•Introduction of new technology (Instron 34SC Pull Tester) to manufacturing site.•ECO Implementation. (creation and modification of procedures)•Managed CAPEX activities aimed at projecting costs for production line implementation.•BOMs of finished goods.•AP & OBS follow up through etQ system

• Transfer of diagnostic and therapeutic manufacturing lines to Costa Rica.• Equipment equivalency analysis.• PFMEA Analysis • Manufacturing technical support to External Manufacturer from end to end of process.•Gather discrepancies from process and internal documentation.• Analysis of equipment requirements and layout for external manufacturing site.• Delivery of BOM list and quantities used in finished good. (Materials, components, tooling and chemicals list; projection of costs and quantity with support of JDE system)•Custom/exportation process of equipment