Michael Leen
About Michael Leen
Michael Leen is a Senior Validation Engineer at Boston Scientific with over 15 years of experience in the pharmaceutical industry, specializing in validation protocols and risk assessment.
Current Role at Boston Scientific
Michael Leen is currently serving as a Senior Validation Engineer at Boston Scientific, a position he has held since 2021. Based in Galway, County Galway, Ireland, Michael’s duties include managing validation support for new product and equipment introduction. He is responsible for assigning validation activities to the team and actively participates in continuous improvement initiatives. Additionally, Michael mentors junior team members and resolves issues that arise during validation processes.
Previous Experience in Validation and Quality Control
Before joining Boston Scientific, Michael Leen was a CQV Engineer at Hyde Engineering + Consulting from 2018 to 2020, based in Westport Mayo. His career also includes a tenure at Mylan as a Research and Development Analyst III from 2017 to 2018, and roles at Allergan in multiple capacities such as Microbiology Projects Team member and Technical Support. Michael has worked as a Quality Control Lab Analyst at AbbVie and Amgen, and as a Quality Control Analyst at Medtronic and Novartis. From 2005 to 2009, he was employed as a lab technician at UCB in Shannon, County Clare.
Educational Background in Analytical Chemistry
Michael Leen holds a B.Sc. in Analytical Chemistry with Quality Assurance, which he obtained from Cork Institute of Technology in 2004. His formal educational background provides a solid foundation in analytical chemistry techniques and quality assurance principles, equipping him with the necessary skills to excel in various pharmaceutical industry roles. Additionally, Michael attended Institute of Technology, Tralee in 1970 for an unspecified duration.
Technical Expertise and Responsibilities
Michael Leen brings over 15 years of experience in the pharmaceutical industry. His extensive skill set includes writing and executing various validation protocols such as URS, DQ, RTM, SAT, IQ, OQ, PQ, and VSR's. He frequently participates in risk assessment meetings to calculate RPN numbers and reduce risks. In his roles, he has been involved in commissioning utilities, cleanrooms, and equipment, both large and small. His expertise is an asset in his current role at Boston Scientific, where he oversees a range of validation activities and initiatives.