Experience

Medical Devices Industry

• Medical Equipment Manufacturing
• 1 - 100 Employee

• Process Engineer

  • sept. de 2022 - - actualidad



AbbVie

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Validation Engineer

  • jun. de 2021 - sept. de 2022

  ● Created and executed Installation, Operational, and Commissioning Qualification Protocols (IQ, OQ, CQ) for new and existing manufacturing equipment.● Coordinated testing activities with internal departments as required by the project scope of work and schedule.● Generated User Requirement Specifications (URS) and Functional Specifications (FS) for new manufacturing equipment.● Initiated, updated and revised Standard Operational Procedures (SOP).● Responsible for creating Commissioning and Qualification Plans for multiple projects.● Developed project status reports to managers and internal teams on weekly cadence.● Collaborated with cross functional teams in the development of Failure Mode and Effective Analysis (FMEA).● Planned and facilitated meetings with cross functional teams to complete tasks required by the project.● Facilitated the documentation and information flow between the different groups involved in processdevelopment.



Medtronic

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Validation Engineer

  • ene. de 2021 - jun. de 2021

  Assisted in the relocation of multiple equipment from one manufacturing line to another, with the purpose of adding new equipment that would increase the production of medical devices in the organization. Responsible for developing Validation Master Plan, IQ Plans & Reports, System Requirements Specification and coordinating the execution of validation protocols.● Presented and received approval of the IQ plans during the Validation Board Forum, which led to bringing the project back on track.● Identified and worked with cross-functional teams in correcting non-conformance and deviations on the calibration procedures and process operations description.