State of Validation 2026

Donncadh has 18 years’ experience across validation disciplines, including process & product validation, equipment and automation qualification, facilities, computer systems, test methods, & cleaning validation. A published author & KENX Editorial Board member, he is also Chair of the BPCI Validation Group.

Durward has over 30 years of hands-on experience with Validation, Qualification, Compliance and Project Management within the Life Science industry. He has experience in a variety of industrial sectors including pharmaceutical, biotechnology, medical devices, food, & healthcare. He has experience in both greenfield and cut and carve brownfield projects in FDA & EMA GMP regulated environments working on behalf of professional services companies.

Marcelo is a senior life sciences validation leader with over a decade of experience in digital and computerized systems validation (CSV). Currently Consultancy & IT Manager at Telstar Brasil, he has led global CSV, SAP implementations, and GxP compliance initiatives, with prior roles at Brainfarma, EMS, AG3 Solutions, and Boehringer Ingelheim.

Michael brings over 10 years of CQV experience and a proven track record of delivering validation projects. In his role, he oversees client deliverables on PM Group’s Kneat instance as well as supporting clients to successfully implement and optimize their own Kneat deployments. With Power‑user expertise, Michael can identify opportunities to streamline processes, unlock efficiencies, and proactively address potential roadblocks.

Ruairí McGarry is an experienced engineer with over 10 years’ experience in quality regulated manufacturing. Prior to joining Kneat, Ruairí held various Project Engineering roles in the medical devices industry, working with Johnson & Johnson, Stryker, and Depuy.