Aidan Harrington is a Senior Project Manager and Regulatory Consultant with DPS Engineering based in Cork, Ireland. He has a B.Sc in Microbiology and a Ph.D in Microbial Genetics from University College Cork. He has worked exclusively in the Pharmaceutical Industry since 1992, in Quality, Validation, and Project Engineering roles. Prior to joining DPS in 1999, he worked for 7 years in Quality and Validation roles in an Aseptic Manufacturing Facility with Fermentation, Purification and Aseptic Filling processes. Since 1999, he has worked on pharmaceutical design and construction projects in Ireland, UK and mainland Europe with responsibility for Validation and Commissioning and Qualification programs up to Commercial Manufacture. These projects included API (chemical and biological), Fill Finish and Secondary manufacturing facilities which were Greenfield and existing facility and site expansions. He has completed two Fill Finish projects since 2008 which involved the installation of vial filling lines with isolators. He acts as a Regulatory Consultant for facility design and the implementation of Risk Based C&Q programs for a broad range of Pharmaceutical clients. He is a member of ISPE since 1999, was on the ISPE Irish Chapter Committee from 2000 - 2006 and acted as Secretary of the Ireland Chapter from 2004 – 2006.