José Ortiz

José Ortiz has a diverse range of work experience in the pharmaceutical and medical imaging industries. José began their career as a Cleaning Technician at Genzyme, where they followed cGMPs, GLPs, GDPs, and SOPs while performing daily cleaning tasks in regulated environments. José then worked as a Manufacturing Technician II at Lantheus Medical Imaging, following cGMPs, GLPs, GDPs, and SOPs while performing various tasks involving chemical handling and purification. José later joined Acorda Therapeutics, Inc. as a Manufacturing Associate, where they operated and troubleshooted manufacturing equipment and process control systems in adherence to cGMPs, GLPs, GDPs, SOPs, and batch records.

José then transitioned to DPS Group Global as a CQV Engineer IV, where they generated and executed commissioning/validation protocols for utility systems and equipment. José also managed project hours and tasks to meet budget and client expectations. Subsequently, at Lantheus Medical Imaging, José worked as a Process Engineer II, participating in the transfer of processes to contract manufacturing organizations. José also generated and reviewed SOPs, FMEAs, protocols, and regulatory submissions, and provided technical support to manufacturing operations.

Most recently, José joined CAI as a Project Manager/Validation Engineer. In this role, they generated master validation plans, FMEAs, SOPs, and protocols for various systems and equipment. José conducted CSV qualifications for specific systems, managed projects, personnel, budgets, and deliverables, and reviewed and approved documents to meet client standards.

José Ortiz's education history includes a Master's degree in Business Administration and Management, General from the University of Massachusetts Lowell, which they obtained between 2019 and 2021. Prior to that, from 2013 to 2017, they pursued a Bachelor of Engineering in Chemical Engineering, also at the University of Massachusetts Lowell. Before entering the university, they completed an Associate of Science in Biotechnology at Middlesex Community College from 2011 to 2013.

Additionally, José Ortiz holds a Computer System Validation (CSV) Professional Certification, obtained from the Biopharma Institute. The specific month and year of obtaining this certification are not provided in the given information.