Project Manager, Johnson & Johnson
“I’ve worked with Bio-Chem for the last three years on a biological manufacturing process scale-up; this tech transfer project included commissioning, installation and qualification of tailor made equipment, which was which was built to meet the unique needs of the manufacturing process, building of ISO6 level clean rooms, validation and qualification of clean rooms.
Eran Yona and the Bi-Chem team were deeply involved in the project, particularly during engineering testing and qualification stages (commissioning), equipment validation for critical systems, and in the verification and validation processes. Eran acted as both a consultant to teh Bio-Chem team during the project (mainly for training, direction, professional knowledge deviation investigations, problem-solving, etc.) and he also directly gave support in a number of project critical activities which Bio-Chem provided in the framework of the project. They performed at a high level, and provided documentation in compliance with requirements for the system ad the manufacturing processes of two types of sterile bio-pharmaceutical products, manufacturing processes, control systems, automation and more, for the critical control and automation programs and systems of the project. It required active intervention and keeping to challenging and tight timeline, and in compliance with the regulations, done responsibly and within the limits of the schedule and budget.”