Massimo Ghelfi Email & Phone Number

Piacenza, It

Piacenza, Italia

Based on the previous experiences, taken-over the software innovation role inside the company with the mission to:• promoting a continuous innovation process of the automation systems, based on the Industry 4.0 principles, • tracking new trends and market requirements.• Supporting company in fast implementation and release of unique and innovative technology solutions to the worldwide pharmaceutical industry.• acting as company ambassador of the software/automation innovations, to share experiences with customers, suppliers and professional organizations.

Member of the company Management Team Board.Automation team leader: people recruitment, empowering, coordination.Reference for the definition and implementation of the company automation strategy, based on a customer centric approach and the technologies innovation: • frequent contacts with customers, for understanding/exploring needs and problems and propose new solutions;• continuous scouting of new software-hardware technologies and POCs management • management of long-term strategic partnerships with automation market leaders, in a win-to-win perspective.Responsible of the Quality by Design, validation procedures and compliance documentation, for all types of automation systems (GAMP5, CFR21p11, Data Integrity, PHARMA4.0) Coordination of innovation projects based on INDUSTRY 4.0 technologies, with partner companies and universities, such as:• modelling and simulation technologies in control systems design;• robotized handling plants for pharmaceutical sterilization of batch productions;• process controller with integrated several technologies: embedded system, DCS and PLC;• design of user interfaces based on user experience concepts• POC of robotized isolator for advanced aseptic productions.• IoT integration of pharmaceutical machines (data collection and cloud/edge computing platforms), to release new services: predictive maintenance, data backup in cloud, application of analytics on big data, remote assets management and monitoring.• research projects on advanced robotics with teleoperation.Participation in trade fairs and symposiums, as the company automation expert.Lecturer in company events, training and workshops and in several national technical conferences and seminars.Management of the worldwide post-sale support and services (ticketing) for the automation components.Responsible of the Safety - Health - Environment Integrated System for the automation department (from Sept 2012).

Manager of the automation department (I have setup), with in charge all computerized control systems installed on the company pharmaceutical machines (sterilizers, decontamination system, washer).Management of all activities related to the control systems life cycle (GAMP5 based): from research and conceptualization of new systems, through design, development and qualification, up to maintenance and customers software support. Coordination of teams in complex (short, medium or long term) projects, following in all operations the highest quality standards and guidelines, required in pharmaceutical market.Project manager of the “Thema4 project”, the most advanced embedded controller for pharmaceutical sterilizers, decontamination and washing machines (more than 2800 installations all over the world, in the main pharmaceutical companies).

Setup of the Automation Department inside the companyDesign, implementation and validation of control systems (PLC-SCADA) for pharma, hospital and laboratory sterilizersDesign of control system for washing/scrubbing machines using the advanced process technology: extractive power of carbon dioxide at supercritical state. Integration of sterilizers legacy controllers in pharmaceutical plant, by using standard protocols.

Pavia, Italia

Responsible of the implementation and certification of the ISO9001 Quality System.Company representative in European Community research project ESPRITSupervisor of the automation department.Software designer for metrology robots and tools presetting stations, for automotive, aerospace and manufacturing industry.

Milano, Italia

Firmware designer in the first digital telephone exchanges ITT1640: adaptation to the italian communication standard.