Amgen AOH (Ohio, USA) - Sr. C&Q Engineer at New Amgen Ohio Site USA. In charge of the development and execution of validation cycle documentation including FAT, SAT and Commissioning and Qualification exercises for all site packaging lines. Serialization Platform - Systech.Abby (Barceloneta, PR) - C&Q Lead resource assigned to the 6K AB29 Project. The responsibilities include the generation, verification, and execution of validation lifecycle deliverables such as URS/FS, Design Qualification, Validation Plans, IQ, OQ, PQ and FMEAs related to the facilities and utilities upgrade of the 6K Area at AbbVie (ABL). Project validations was extended to other impacted systems such as the site PLC network, PI Historian System, Building Management System (BMS) and Delta V.Amgen AML (Juncos Site) - Principal Engineer at the Process Development Department for the Characterization of Packaging Equipment (Case Packer / Packaging Line 4137). Serialization Platform - Systech.Bristol Myers Squibb (Manatí Site) - Responsible to assist as Validation Specialist (IT Department) in the execution of the SAT and IOQ protocols for the Serialization of Packaging Line 1605 at Bristol Myers Squibb (Manatí Site). Serialization Platform - Traxeed.

Johnson & Johnson, Ortho Bio & Pharma Site Divisions – Gurabo/Manatí, PR:Directs and coordinates team activities in the implementation of the Windows 10 project to upgrade laboratory equipment (Densitometers, TECAN), packaging labeling applications (EasyLabel), Systech Serialization System (Guardian), KepserverEx OPC and Apache TomCat Web Server. The responsibilities include the generation, verification and execution of validation lifecycle deliverable such as GxP Assessments, Validation Plans, IQ, OQ, PQ, Risk Assessments, Annex 11 Assessment, 21 CFR Assessments, URS, SDS, Traceability Matrix and decommissioning for the Janssen-Ortho Biologics (Manatí) and Janssen Pharma Divisions (Gurabo). Laboratory qualification performed using the “ONE JSC Lab Standards” methodology. Implementation of the HP ALM program at the Janssen Gurabo site. HP ALM is a web base tool used to perform and manage validations and defects/deviations of GxP system electronically.

Thermo Fisher Scientific (Patheon) –Manatí, PR: Responsible of the generation and execution of IOQ protocols for the Technical Operations Department specifically for the Serialization Project to be implemented at Secondary Packaging Lines 9010, 9020 and 9060 using the Optel Vision Systems.Johnson & Johnson, Ortho Bio & Pharma Site –Manatí, PR: C&Q Department (J&J) Responsibilities included the preparation and execution of Validation Studies, Commissioning Forms, Installation/Operational/Process Qualifications Protocols, Summary Reports and Validation Plans for the following systems: general facilities (Gown/De-Gown, Manufacturing Transition and Production Areas), compressed gases (clean air), HVAC units, controllers (equipment) upgrades, LabX & Q-Doc application, AT4, Sotax, RAMAN RM TruScan (Spectroscopy Technique) and machine equipment. Engineering Department (J&J) Responsibilities and roles included the performance of investigations for the Utilities/Engineering Department at the Biologic and Pharmaceutical Business Units, Ortho J&J Manatí site.Becton & Dickinson – San Lorenzo, PR: Responsibilities and roles for this project included: the preparation and execution of IQ/OQ/PQ protocols associated with equipment remediation plan related to CAPAs (NG, MBT & Multivac). Execution and configuration of experiments using, Design of Experiment, Measurement System Analysis, and technical report (Engineering Studies). Coordination with vendor and equipment supplier for the installation of equipment upgrades. Revision and verification of drawings as part the equipment modifications. Coordination of the logistics involved (Manufacture, Material Supply and QA) for the execution of all validation and engineering activities. SOP generation and training

Directs and coordinates engineering activities concerned with development, installation, and calibration of instruments, equipment, and control devices required to test, record, and reduce test data. Review and correct qualification documents for equipment qualification protocols according to the cGMP’s and company policies. Write and execute validation protocols such as commissioning, IQ, OQ and PQ for facilitates and utilities systems. (Companies: Cardinal Health, Abbot, GlaxoSmithKline and Amgen.)Amgen - Juncos, PR: 6X AML Expansion Project. Responsibilities and roles for this project included: Documentation Package Turnover coordination, preparation of turnover plans, conducting walk downs with contactors and Amgen personnel using construction, P&IDs and Isometric drawings to ensure system completion. Also perform as a QA specialist for the verification of the piping passivation reports. GlaxoSmithKline - Cidra, PR: Responsible for performing the Validation Master Plans and protocols for the Packaging and Granulation Suites Upgrade Projects at CCCP Cidra II (solid dose packaging lines). Both projects were required to comply with FDA commitments. The documentation cycles on these projects were as follows: URS, VP, FRS, Enhance Commissioning, Traceability Matrix and Summary Reports.Abbott Laboratories – Barceloneta, PR: Responsibilities included the preparation and execution of validation studies, including Commissioning, Installation and Operational Qualifications Protocols, and Summary Reports for the following systems: Transfer Panels, Buffer Hold Tanks, Filter Carts, and Portable Tanks.Cardinal Health – Humacao, PR: Execute validation activities related to the new manufacturing Sterile Core Area (Class 100) start-up of the Abbott/Humira product, including the following areas: Facilities Qualification, process and manufacturing of the Filling refrigerator equipment.

Preparation and execution of IQ/OQ/PQ Protocols for Needles (Spinal, Whitacre, Quincke, Multipurpose). Protocol development included process assessment, development and analysis of Design of Experiment, process optimization, determination of process capability and Gage R&R Studies.

Developed, evaluated, and improved manufacturing methods, utilizing knowledge of product design, materials and parts, fabrication processes, tooling and production equipment capabilities, assembly methods, and quality control standards. SOP development for equipment and process on Radio Frequency Tip Forming Machines. Product Transfers between USA and PR on Access Device Products (AVA, Multi-Med, Vantex, Dilators, and Introducer Sheaths) - Lead new product transfer from off shore facilities and develop process technology to enhance existing operations. Responsibilities included the coordination of resources, and the planning of all the activities related with the product transfers, validation & implementation (IQ/OQ/PQ). Process development included the use of statistical tools as design of experiments and R&D coordination for experimentation on new processes.Responsible of line support on daily issues such as scrap, line efficiencies, process troubleshooting and the creation of preventive maintenance programs for equipment. Supervise 10 operator and mechanic employees.