Suggestions
Dror Magen
Production Manager at ENDOSPAN
Dror Magen is a Biotechnology Engineer with a Bachelor of Science degree and more than a decade of experience in the Pharmaceutical, Biotechnology, and medical device industries. His professional background includes roles as a process engineer, validation team leader, and manufacturing and engineering manager.
His specialties encompass a wide range of project management tasks, including the generation of various validation documents and assessments like VMP, VP, DQ, IQ, OQ, PQ, PPQ, Impact, Criticality, and Risk Assessments. Dror excels in troubleshooting, providing guidance on Validation Life Cycle processes, change control, change management, GEP, and GMP compliance.
Dror's expertise extends to validation of processes, cleaning procedures, SIP and Incubator systems, Autoclaves, depyrogenation ovens, utilities (HVAC, OFA, Steam-HTM, WFI, and CIP/SIP systems), and Packing Line Validation. He also conducts studies on process optimization, troubleshooting, root cause analysis, and implements effective solutions and corrective actions.
Additionally, Dror is skilled in process and cycle development studies, clean room qualification, risk assessment, and justification. He is adept at preparing and presenting validation documents to regulatory bodies such as CE, FDA, IMOH, MHRA, TGA, customers, and other stakeholders, demonstrating a deep understanding of pharmaceutical regulatory requirements.
In terms of education, Dror pursued an MBA in Multidisciplinary Management at Netanya Academic College and obtained a B.Sc. in Biotechnology Engineering from Ort Braude College. Throughout his career, he has held pivotal roles at various organizations, including Production Manager at ENDOSPAN, Process Group Manager at Medinol, Manufacturing and Engineering Manager at Sam-on Meditec, Process development and manufacturing supervisor at Ayana Pharma Ltd., Validation Team Leader at Omrix, and Process & Cleaning Validation Engineer at Taro Pharmaceuticals.