Kevin Owen
Global Aseptic Fill Finish Subject Matter Expert
Kevin Owen, Global Aseptic Processing subject matter expert
Microbiologist by profession (Hospital and Pharmaceutical), Aseptic operations by choice.
During his 30 years of aseptic operational activities he has been responsible for all aseptic processing capability within multinational Pharma. He ensured all industry and regulatory expectations were met (and anticipated) across sites by embedding a systemic approach to aseptic manufacturing.
He has led draft Annex I compliance strategy, and set up and developed Aseptic centres of excellence to transform aseptic assurance cultures.
Expert fields include Regulatory compliance, positive and negative pressure cleanrooms, toxin handling, lyophilisation, specials manufacturing, clinical trials, and Laboratory design. He has led major aseptic facility improvement projects without interruption to the commercial supply of products to patients.
His position as Aseptic Processing subject matter expert provides great technical leadership and operational depth on aseptic fill finish projects across the global footprint of the PM group.
He is always Patient centric
Microbiologist by profession (Hospital and Pharmaceutical), Aseptic operations by choice.
During his 30 years of aseptic operational activities he has been responsible for all aseptic processing capability within multinational Pharma. He ensured all industry and regulatory expectations were met (and anticipated) across sites by embedding a systemic approach to aseptic manufacturing.
He has led draft Annex I compliance strategy, and set up and developed Aseptic centres of excellence to transform aseptic assurance cultures.
Expert fields include Regulatory compliance, positive and negative pressure cleanrooms, toxin handling, lyophilisation, specials manufacturing, clinical trials, and Laboratory design. He has led major aseptic facility improvement projects without interruption to the commercial supply of products to patients.
His position as Aseptic Processing subject matter expert provides great technical leadership and operational depth on aseptic fill finish projects across the global footprint of the PM group.
He is always Patient centric