Plant project engineering/leader in the execution/support and implementation of a ($)28M projectfor the upgrade of the LFVA MB+ medical solution product line. Project consists in ensuring the fullinstallation and commissioning of 4 new injection molding machines, 7 subassembly molds and theinstallation, the upgrade/revamp of a 2UP subassembly vail adapter machine for the Low ForceValve Activation Mini-Bag plus (LFVA MB+) product line.• Plant project engineering/leader in the coordination of a 60K sq-ft ($)200M expansion to extendmanufacturing capacity for the Small Volume Parenteral (SVP) Intravenous (IV) Solution in theMB+ format for Baxter’s Cleveland site. This is a strategic project that added network capacity,strengthen, and grow Baxter’s leadership position in the IV Solutions SVP market.• Managed the proposal justification process (Charter/CER/PPT/FEL2) for the expansion project forMOD2 ($9.9M) area that included an additional 3500 sq-ft, purchase of 8 Injection Moldingmachines and their respective molds plus related plant utilities for these and installation schedules.• Identified process improvements: (1) in existing IM machine improving cycle time by 1.4s yieldingand extra 6600 units/day (19.2% increase in capacity / day – 1.584M u/y – ($)223K increase inabsorption. (2) Vialmate device assembly automation project – ($)660K labor savings.• Prepared capacity analysis for molding Department (Involved molds/molding machinesperformance over six-month period).

• • Project management execution/support in the implementation of an automated vision inspection (aid operations in detecting particle matter) system across 34 Kiefel machines (3 year span 2018-2020).• Project management support (validation) in the implementation of a new solvent applicator across all fill lines (19 fill lines – 2 year span 2018-2019). New applicator reduces the amount of cyclohexane (waste) and improves the solvent application on the connector assembly reducing significantly leaks due to lack of solvent.• Supported the development of the URS requirements for the remediation process of the Distilled Water (DW) / Water for Injection (WFI) system improvements (Current system had numerous leaks and micro hits). Develop the SOW requirements for the project and participated directly in the contract selection resources that would execute the tactical work.• Implemented the action items required for the WFI system improvements by executing the installation of new high pressure clamp and gasket, correcting pipe slope, changing current pipe supports to a more robust static/dynamic model type, eliminating check valves and improving sample site collections by managing/planning schedule activities directly with the subcontractors and plant Materials/Manufacturing/Facilities and Quality areas.• Communicated weekly project status to members of the SLT (senior leadership team).

• Supported and executed the CAPA process following the company’s six step procedure approach system. Remediated CAPA(s) related with labeling issues: verifying labeling content and labeling instruction for use content assuring that these comply with the General Device Labeling Regulations – 21 CFR part 801.• Wrote, supported execution and verification of protocols as part of the corrective / preventive action phases for Labeling CAPA.Mentored / Coached and supported company CAPA engineers through the CAPA process

Managed and supported the relocation and transfer of the receiving inspection (RI) area to a new designated building. Reviewed product flow and layout to assure process efficiency. Develop (using Microsoft project) and approved project plan as per approved guidelines. Managed and address project deficiencies and/or situations to assure that project was completed on time, met expected results and on budget. Implemented measuring metrics at RI to increase daily thru put from 30 to 50 inspections per day.Managed and worked in conjunction with supplier quality engineering to support the Mfg. product (RI/CT/TF/AMI)lines during the remediation process by reviewing, approving and assuring components were in compliance through the PSV Product Specification Validation) and SPQ Supplier Part Qualification) processes. Executed as primary Quality Chairperson on daily RI/Operations MRB meeting. Supported execution/resolution of Quality Notifications QN), SCAR, CAPA, Quality Plan and Ship Hold processes.

Owned Class 2 Nonconformance Records and perform entries to maintain Trackwise records updated, ensuring information is clear, concise and portrays an accurate summary of the investigation conducted. Develop Investigational Reports; Provide follow-up on Statistical and Process Development Assessments, and Corrective/Preventive actions issued as a result of Class 2 NCs; participate on events triage meetings within the established goal. Coordinate and conduct interviews with personnel of different areas to investigate events related to Class 1 or 2 NCs. Communicate effectively progress of investigations in the nonconformance meeting, as required. Present new nonconformances in the Nonconformance Review Board (NCRB) meeting, present CAPA proposals to the CAPA Review Board (CRB) and manage NC/CAPA closure within established goal. Present NCs overview to the Site Review Board (SRB) in order to receive approval for inspections of batch affected portions and/or next steps for the investigations, as applicable.

Lead the Amicus/Alyx subassembly products and Heat Seal RF products. Lead and supervise team of 2 superintendent and 2 supervisors. In charge of product lines compose of 14 subassemblies working 3 shift operations 5 to 6 days and a final product with E-beam sterilization working 3 shifts one week a month. Responsible for supplying 9 primary products to the Haina plant (Dominican Republic) and 5 products to the Maricao plant. Manufacturing assembly operation consists of high technology robotics, automated transport system, Testra leak testing equipment, RF sealing, Branson ultrasonic sealing, automated robotics-programmed equipment and manual solvent sealing assemblies with ergonomics attributes. Responsible for a work force of 260 employees between 5 day week and weekend shift with total VOP of 28mm.

Lead the Device Autopherisis subassembly operations. Lead and supervise team compose of one superintendent, 3 supervisor, 5 leads and a record keeper. Responsible for the 3 shift operation of product, producing average of 10 mm units per year yielding a VOP of 22mm.Manufacturing consist of High Technical equipment involving Stubli robots (6 axis), Branson sonic seals, electrical linear encoders, pneumatic stations, optical inspecting systems, controlled by PLC (latter logic program) communicating between 3 enclose modules.Responsible for the Device product transfer from Añasco (Bentley Building) to the San German Plant in 1995. Also gave direct support in the transfer of the Reservoir product assembly machines from San German Plant to the Haina Plant in Dominican Republic.

In charge of A-shift operations as, supervise directly 4 leads, a record keeper and 64 assemblers for the Device and Reservoir operation.

Involve directly in product transfer for the Device and Reservoir assembly machines from Santa Ana, California to Añasco, PR. Worked directly with the product start-up at the Añasco Plant. Develop the procedures, standard and structures, specification and validation. Supported shift start-up for these processes.

Worked in the industrial Engineering and technical service department. Responsible for and maintaining standards for the Heat Seal, Subassembly and Tube and Needle departments. Had the responsibility to give direct support to plant VIP program, which total 6mm between 1985 and 1988.