Andrea Simonetti Bonfiglioli Engineering

Andrea Simonetti received the MS degree and the PhD degree in electronic engineering from the University of Ferrara, Italy. Since joining Bonfiglioli Engineering in 2002 as Validation Manager he has successfully led large scale commissioning, validation and quality projects for worldwide major pharmaceutical regulated companies.

Andrea is currently the Director of Pharma; he leads the planning and strategic direction of the pharmaceutical business unit, defines continuous improvement and innovation tasks, programs development, company business growth targets, manages customer relationships and technical training. Andrea is a frequent speaker at conferences and seminars including ISPE, PDA, BFS IOA. His most recent publications involve developing Process Analytical Technology, Lean Six Sigma and Operational Excellence strategies for pharmaceutical equipment used in Container Closure Integrity field; he is currently working with PDA “Technical Report 27 – Pharmaceutical Package Integrity” re-write task force team and Prefilled Syringes group.