JOSE CAMARA SANTIAGO, Validation Engineer, Catalent Pharma

José has more than 20 years of experience in the Pharmaceutical, Medical Devices and Biotechnology industry. His expertise has been focused on Computerized System Validation (CSV) Projects in compliance with FDA 21 CFR Part 11, CFR 820, GAMP 5 and ISO 13485 standards. Possess strong background in CSV projects to support QC Analytical Laboratories and manufacturing operations according to SDLC Methodology. Experience with diverse Quality Systems Management. For example, CAPA & Investigation, Change Control, JDE, Maximo, etc. Strong exposure to work in the FDA, ICH, DEA, ISPE and PDA regulated environment oriented to the high level of quality standards. Experience in Process Excellence and Lean tools. Professional experience supporting and leading projects for new technology/equipment, aseptic rooms, process improvement, technology transfer, etc. Expertise working with Logical Controls based in Manufacturing Equipment controlled with PLC (Ladder), and HMI. Experience in Line Level Serialization Technology Projects. Expertise with the new implementation of the Optel TrackSafe Serialization System in Packaging Portable Lines and HERMA High Speed Bottle Line Level Serialization. Experience leading Engineering Projects.

José holds the following certifications: Certified Quality Auditor, Certified Quality Engineer, and Six Sigma Green Belt per ASQ.

Native of Puerto Rico, José holds a Bachelor of Science (BS) with a major degree in Chemistry and a minor degree in Mathematics from the Interamerican University of Puerto Rico, Metropolitan Campus.