Obed Rodriguez

Experience

1. Senior Validation Engineer

   Illumina

   May 2022 — Present · San Diego, CA, US

   Represent the Consumable Validation group in a cross functional NPI project teams, ensuring validation requirements and deliverables are communicated to the teams.• Develop and articulate robust strategies for validation of processes and systems through development and release of holistic validation plans.• In collaboration with end users, process owners, Quality Engineers and other team members, develop validation protocols and oversee execution of IQ, OQ, PQ for manufacturing processes and systems.• Write reports summarizing results and statistics for all equipment and process validation projects.• Be accountable for timely completion of all validation deliverables in accordance with project timelines.• Provide consultation to other departments performing validation activities.• Provide input for creation of requirements documents.• Actively participate in creation of risk management documents such as pFMEA for systems and processes.• Perform job function in compliance with the internal procedures and applicable external regulations and standards, e.g. FDA, QSR, ISO-13485.• Initiate and execute controlled document change requests.

Education

• Institute of Technology of Sonora

  Bachelor of Engineering - BE, Industrial Engineering

  2007 — 2011

• Tecnológico de Monterrey

  Master of Engineering - MEng, Automotive Engineering Technology/Technician

  2012 — 2012