Blue Bell, Pennsylvania and Birmingham, UK, August 18, 2022 – IPS-Integrated Project Services, LLC, a leading provider of engineering, procurement, construction management, and validation (EPCMV) services, welcomes Kevin Owen to its EMEA team as Director of Aseptic Technology. Located in Birmingham, UK, Kevin will provide technical consultation on the regulatory challenges in a pharmaceutical operation, as well as oversee aseptic technology projects for clients within the EMEA region, which includes offices in the UK, Ireland, Switzerland, and Germany.
Kevin is an experienced aseptic fill finish subject matter expert (SME) with over 30 years of expertise within pharmaceutical operations and QC laboratory management. A microbiologist by training, Kevin specializes in ensuring aseptic fill finish processes, QC laboratories and advanced therapy medicinal product (ATMP) facilities comply with all regulatory requirements. Kevin has managed product life cycle compliance from early-stage clinical trials to full commercial capability. He has experience installing new lines and equipment within an existing facility while retaining commercial capacity. He is adept at understanding and navigating regulatory guidelines from his time as the client, with expert knowledge of CGMP and current/future compliance expectations, including draft Annex I. Kevin regularly lectures at international aseptic conferences. He is unique in supporting end-to-end projects from the early stage feasibility to end-stage CQV practices and operator training, and his operational expertise differentiates him.
“We are delighted to welcome Kevin to the IPS family,” said Daryn Jenkins, Managing Director, EMEA. “His experience and energy are key to delivering our projects across EMEA and ensuring that our clients’ voices will be carried through the implementation phase of all of our projects. I’m so pleased he has decided to join our team.”