BIOGRAPHY Mr. Kovacs focuses on operational excellence, innovative technologies, product quality and CGMP regulatory compliance. Ken has in-depth experience working with successful companies including Johnson & Johnson, TAVA Technologies and Rockwell Automation. His capabilities include management of engineering, operations, business transformation, maintenance and facilities as well as launching and developing new businesses and technologies. Ken has in-depth experience with the implementation, validation, and management of projects, technology, automation, production equipment, quality systems, MES, and complete solutions to address company objectives and increase profitability. Mr. Kovacs approach to driving solutions includes proven methodologies with standardized models to define requirements, assess risk, analyze processes, provide justification, develop solutions, and implement successful programs. MBA – Xavier University Bachelor of Engineering – Villanova University
Ken is an active member of ISPE and GAMP America’s MES Special Interest Group. He is an original member of the ISA-95 committee developing the “Enterprise-Control System Integration” standard, a past Director of ISA’s Food and Pharmaceutical Industries Division, and a co-author of the textbook “Automation and Validation of Information in Pharmaceutical Processing”. Mr. Kovacs is a published author and speaker with over 70 articles, whitepapers, presentations, and seminars.
Ken Kovacs: Senior Leader & Certified Management Consultant (CMC) Operations – Engineering – Compliance “Driving Product Quality and Company Profitability through Operational Excellence, Technology, and Regulatory Compliance” Providing insightful leadership, innovation, technology, and continuous improvement to achieve corporate objectives for Life Sciences and other globally regulated industry companies Developing first generation systems and processes, improving the performance of existing operations, and launching new businesses to quickly facilitate achievement of organizational goals Developing global standards and guidance to reduce lifecycle costs and increase performance for quality systems, audits, operations, engineering, processes, projects, validation, and supply chains