• Performed assessment on previous TMV reports to verify compliance with current procedures and Work Instructions. • Updated reports, or performed revalidation for the reports that were found to be inadequate as per current procedures.• Performed assessment on current measurement systems to determine if was required to be included in Remediation Plan.• Developed and executed TMV protocols for attribute and variable measurement systems.• Performed statistical analysis (Gage R&R) using Minitab for executed protocols.• Developed TMV Reports for executed protocols.• Updated Master Validation Plans (MVP) to include the completed remediation activities

• Leaded the Validation activities in Jayuya site for Laboratory Analytical Systems for a global Remediation Project; Computer Systems Integrity (CSI).• Supported other Baxter sites included in the CSI Remediation Project during the validation documentation developing and review.• Performed Gap Analysis in order to develop a validation strategy based on the gaps found for Laboratory Analytical Instruments.• Developed a Validation Strategy for 39 laboratory systems focused on remediate gaps in order to comply with CSI scope and 21 CFR Part 11 Regulation.• Performed full qualification for software that was upgraded as part of the CSI Remediation Project.• Follow defined validation approach in managing the validation activities including developing Risk Assessment/FMEA. • Developed, Executed, Review and approve Validation Plan, User Requirements Specification, validation protocols IQ, OQ, PQ, CSV, Test Cases, Test Incidents/Deviation, Traceability Matrix, and Validation Summary Report for Laboratory Analytical Systems software.• Revised and developed SOP’s for Laboratory Analytical Systems in project scope

• The project consisted on the installation of a manufacturing line for a new product that will be incorporated to the Villalba site.• Tasks included: Develop and execute IQ and CSV protocols for equipment, develop calibration procedures, preventive mantinance and SOP's for the equipment and coordinate with the respective department and/or manufacturer for validation, installation or movement activities

•Performed assessment for Measurement Systems use in the manufacturing areas for measurement of Critical to Quality features in order to determine requirements for Test Method Validation.•Developed Validation Work Orders in order to manufacture samples with different specifications for Test Method Validations. Trained operators to manufacture samples in accordance with Validation Work Order.•Responsible to Measurement Instruction Sheet (MIS), Feature Inspection Plan (FIP) and Feature Criticality Assessment (FCA) assessment.•Developed and executed TMV protocols for attribute and variable measurement systems.•Performed statistical analysis (Gage R&R) using Minitab for executed protocols.•Developed TMV Reports for executed protocols.•Researched with the actual measurement systems on how to improve methods. •Developed fixtures and drawings in order to improve measurement methods. Fixtures were approved for manufacturing use.

•Researched and analyzed both new and already existing materials and analyzed use suitability.•Conducted inspections of materials already in use and performed testing.•Performed Feasibility Study to show documented evidence of the impact of supplier material change in the manufacturing process and final product.•Developed Technical Summary to show feasibility study results.•Developed and executed Material Qualification (MQ) in order to release new material.

•Developed and executed validation documents (TMV, IQ, TFIQ, FAI) for Remediation project to outline Processes, Equipment and Test Methods used for Incoming, Manufacturing, and Packaging processes. •Evaluated potential process weaknesses and failures by reviewing the PFMEA’s for each manufacturing area in Edwards, PR site. Performed GAP analysis for documents and processes.•Performed statistical analysis for ATMV’s, VTMV’s and IQ’s results using Minitab.•Generated final reports for executed protocols, and deviation reports.•Developed Standard Operation Procedure (SOP) for measurement equipment in manufacturing area.

•Developed and executed Installation and Operational Qualification (IQ/OQ) for automation systems, visual inspection systems and instrumentation, and SCADA systems.•Developed and executed IQ/OQ protocols for the following equipments: Sortimat Demolder Machine, Elma Extraction and Hydration Machine, HH Sealing and Tray Loader Machine and HH Lens and Tray Handling Machine for the new Silicone Lines 3 and 4 MyDay Wet Manufacturing Process at Coopervision.•Developed and executed Installation and Operational Qualification for the following equipments: Layton DK100 Toric Extraction and Hydration Machine and L-Shape Racetrack, Blister Feeder, Marlin Sealer and Labeler for the Fanfilcon A (Sapphire Product) wet manufacturing process.•Executed Installation and Operational Qualification for the Hekuma Vertical Oven system.•Generated and developed deviation reports.•Generated final reports for executed IQ/OQ protocols.•Generated investigation reports and memos.

•Developed a user-friendly digital database that kept track of chemicals inventory and their corresponding material safety data sheets in order to comply with OSHA safety guidelines and the Hazard Communication Standards (HazCom 2012).•Performed chemical inventory, ensure that material safety data sheets were available for each chemical and uploaded MSDSs into digital database.•Performed routine walkthrough inspection of facilities to insure adherence to safety standards.•Maintained MSDS and chemical safety information up-to-date as required by OSHA.

•Provided assistance in preparing validation documents, collecting data and writing reports.•Developed maintenance procedures, periodic reviews, ENG and SOP.•Reviewed and approved memos for FDA ECOs Remediation.•Developed and executed the Installation Qualification (IQ) for Automatic Dispensing Machine in the Bactec Sensor production area.•Performed routine assembly line production functions like cleaning, assembling, and ensuring that valves and sensors were in the correct position and working properly.•Took samples and inspected them during production process ensuring quality of the product.•Maintained accurate records and logs according to FDA regulations and GMPs.•Generate investigation reports.

• Lead a team of five employees ensuring quality, safety and good productivity.• Made visual inspection and took measurements in the project area to determine the amount of product to be used and the equipment needed.