Harris Simon

Background

About Harris Simon

Currently I manage and lead a team of technical support engineers and provide technical support for the specification, purchase, installation and qualification of pharmaceutical plant/equipment. Engineering lead for tech transfer projects including design, URS, FAT, SAT, commissioning/validation, PV batches through to commercial batches in accordance with all applicable cGMP standards and guidelines, which includes compliance with EU and FDA guidelines and regulations.Fault identification, correction and process improvement on existing and new equipment through OEE and lean 6 sigma. Writing of maintenance procedures and critical spare parts holding and FMEAI have a proven, hands-on track record in installation of large commercial projects that include PW and WFI generation and storage, PS generation, complete aseptic production lines to small scale projects of continuous improvements to existing equipment.