Kevin Owen

aseptic fill finish SME with over 30 years’ expertise as a senior operations manager and QC laboratory manager. Kevin specializes in ensuring aseptic fill finish design and processes, QC laboratories, ‘specials’ facilities and ATMP facilities are compliant to all operational and regulatory requirements.

A microbiologist by profession, Kevin has managed facilities and products from clinical trials to full commercial capability, and has hands on experience of installing new lines and equipment within cleanrooms whilst still retaining existing commercial capability.

He is regulatory battle-hardened, and has expert knowledge of CGMP and current/future compliance expectations, including the 2022 Annex 1 revision.

He is unique in supporting end-to-end projects from feasibility to final end stage CQV practices (including dynamic smoke visualization and process simulations) and aseptic operator training.

His operational expertise differentiates him, and he is always patient-centric.