Massimo Ghelfi

Massimo Ghelfi Email and Phone Number

Compliance Manager Consultant @ 40Factory | Industrial Digitalization
Piacenza, IT
Massimo Ghelfi's Location
Piacenza, Emilia-Romagna, Italy, Italy
Massimo Ghelfi's Contact Details

Massimo Ghelfi work email

Massimo Ghelfi personal email

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About Massimo Ghelfi

My consultancy service is based on a long experience on the design, management and innovation of the automation systems for the pharmaceutical industry, acquired in complex and dynamic, international contexts. I am focused on leveraging the digital transformation in the operations areas to increase the business results, by means of a sustainable and valuable innovation.I operate following a multidisciplinary and holistic approach based on 4 pillars to always keep together: the application of Industry 4.0 and Pharma 4.0 technologies and paradigms, the processes review by applying the lean thinking, the assurance of the required compliance levels and the teams collaboration by the involvement of people.

Massimo Ghelfi's Current Company Details
40Factory | Industrial Digitalization

40Factory | Industrial Digitalization

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Compliance Manager Consultant
Piacenza, IT
Website:
40-factory.com
Employees:
25
Massimo Ghelfi Work Experience Details
  • 40Factory | Industrial Digitalization
    Compliance Manager Consultant
    40Factory | Industrial Digitalization
    Piacenza, It
  • Independent Contractor/Consultant
    Automation Compliance And Innovation Consultant
    Independent Contractor/Consultant Feb 2019 - Present
    Piacenza, Italia
  • Fedegari Autoclavi Spa.
    Software Innovation Director
    Fedegari Autoclavi Spa. Jun 2018 - Feb 2019
    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.
  • Fedegari Autoclavi Spa.
    Automation Director
    Fedegari Autoclavi Spa. Oct 2009 - Jun 2018
    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).
  • Fedegari Autoclavi Spa.
    Automation Manager
    Fedegari Autoclavi Spa. Sep 2002 - Oct 2009
    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).
  • Fedegari Autoclavi Spa.
    Automation Department Supervisor
    Fedegari Autoclavi Spa. Apr 1996 - Sep 2002
    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.
  • Speroni Spa
    Supervisor Of The Automation Department
    Speroni Spa Jun 1988 - Apr 1996
    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.
  • Alcatel-Lucent Enterprise
    Electronic Engineer
    Alcatel-Lucent Enterprise Jun 1987 - Jun 1988
    Milano, Italia
    Firmware designer in the first digital telephone exchanges ITT1640: adaptation to the italian communication standard.

Massimo Ghelfi Skills

Automazione Manifattura Industria Farmaceutica Convalida Ingegneria Project Management Norme Di Buona Fabbricazione Sviluppo Di Prodotto Testing Ingegneria Dei Processi Plc Produzione Snella Microsoft Office Integrazione Fda Project Planning Strumenti Medicali Gestione Team Cross Functional Automation Pharmaceutical Industry Engineering Quality Assurance Gmp

Massimo Ghelfi Education Details

Frequently Asked Questions about Massimo Ghelfi

What company does Massimo Ghelfi work for?

Massimo Ghelfi works for 40factory | Industrial Digitalization

What is Massimo Ghelfi's role at the current company?

Massimo Ghelfi's current role is Compliance Manager Consultant.

What is Massimo Ghelfi's email address?

Massimo Ghelfi's email address is mg****@****ari.com

What schools did Massimo Ghelfi attend?

Massimo Ghelfi attended Università Degli Studi Di Pavia.

What skills is Massimo Ghelfi known for?

Massimo Ghelfi has skills like Automazione, Manifattura, Industria Farmaceutica, Convalida, Ingegneria, Project Management, Norme Di Buona Fabbricazione, Sviluppo Di Prodotto, Testing, Ingegneria Dei Processi, Plc, Produzione Snella.

Who are Massimo Ghelfi's colleagues?

Massimo Ghelfi's colleagues are Marco Pozzoli, Valerio Ghione, Claudio Bentivoglio, Nicola Bosoni, Marco Bressanello, Fabio Vesperini, Ph.d, Mirco Domenicale.

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