Shlomi Avraham
Founder & CEO, Senior Engineering Consultant
More than 20 years of engineering leadership, CQV and regulatory compliance in biopharma, medical devices (Class II and III), medical cannabis and food-tech. Since founding Protechtiv in 2015 he has led turnkey facility projects from URS, basis of design and DQ through construction supervision and PQ, including the 6,000 m² Mapi Pharma site, the 4,000 m² cleanroom plant in Hangzhou and an EU-GMP facility in South Africa. He leads CSV for ERP and track & trace systems under GAMP 5, Part 11 and Annex 11, and has prepared and defended FDA and EU notified body audits. Certified ISO 13485 Lead Auditor. Earlier, senior engineering and facility project roles at Omrix (Johnson & Johnson), Perrigo (formerly Agis) and CTS. B.A. in Industrial Management.