European Pharma Maintenance Masters » Speakers

Greg Julich, Global Director/Team Leader, Pfizer Global Reliability Program / USA

Presentation
Pfizer’s global reliability programme

Personal Information

Greg Julich is currently the Director/Team Leader of Pfizer's Global Reliability Program based in Peapack New Jersey. Greg is part of Pfizer's Global Engineering organization; Greg has held a number of technical and engineering positions in his 31yrs of working in the Pharma industry. A practitioner of Lean, Greg has lead numerous efforts in the application of Lean manufacturing and six sigma. Greg is actively involved in the integration of the Maintenance Excellence efforts of the legacy Wyeth organization. Greg holds a degree in Package Engineering from the University of Wisconsin.

Gary Butler, Director of Facilities Engineering UK, AstraZeneca / UK

Presentation
Implementing Maintenance Excellence across the AZ facility maintenance teams in AZ UK Sites to deliver increased value to AZ, and reduce overall costs

Personal Information

Gary Butler is currently Director of Facilities Engineering UK at AstraZeneca. UK Director for asset provision and maintenance delivery for AstraZeneca in the UK. The asset base supported is over 750,000m2 covering 9 locations across the range of Pharmaceutical Research, Supply and Headquarters Sites. This is achieved by leading the delivery of capital projects, managing maintenance service delivery, scientific equipment technical support, and ensuring engineering compliance. I direct AZ internal resources and ensure effective Supplier Relationship Management at the national and site levels involving multi-million pound contracts. The role include interfacing with the wider global organisation to ensure the maintenance excellence strategy is adhered to within UKFM, ensuring understanding and adoption of technology developments and delivering national projects in accordance with global projects strategy. Member of UKFM leadership board with accountability to ensure that UKFM services delivery effectively to meet the AZ business needs. Before he was Headof Site FM at UK Sites. Before he was moving to UK he leads the Astra Zeneca Engineering Team at the plant in Westborough, USA as a Senior Director Site Engineering.

Dr. Christian Jurisch, Principal Engineer, Head of Technical Services Pharma, Global Pharmaceutical Supply Group (GPSG), Johnson & Johnson / Switzerland

Presentation
OEE – Tool for continuous efficiency improvement of packaging lines

Personal Information

Dr. Christian Jurisch is head of the Department Technical Services Pharma at CILAG AG since 2008, being responsible for Maintenance as well as Process Optimization & Packaging Engineering. Before that he held different functions, e.g. in international Project-Engineering or as Head of Site Engineering & Maintenance at CILAG AG. Dr. Jurisch gained his masters degree in mechanical engineering at the Technical University of Darmstadt and completed his PhD in engineering at the Technical University of Munich. He started his professional career at Fresenius AG 1996, as responsible for qualification of a new infusion solutions factory in Friedberg. In 1999 he took over the commissioning project lead of the new build Fresenius Kabi factory in Uppsala/Sweden. There he became head of Technical Department and Packaging Development until he continued his career in Switzerland at CILAG AG in 2002.

Dr. Chandrashekar Nimkar, Head, Technical Competency Center, P.O. Sandoz Baug, Sandoz Private Limited / India

Presentation
Auditing and qualifying suppliers and vendors: An effective risk based approach

Personal Information

Dr. Chandrashekar Nimkar started his career at Ipca Laboratories Limited, India in 1989. In 1990 he changed to Armour Chemicals Private Limited, India where he worked at the quality control department. End of 1990 he started to work at Sandoz/ Novartis India, first as a Quality Control Chemist and, in 1998 as a senior executive in QA. In 2000 Dr. Chandrashekar Nimkar changed his responsibilities as a senior manager in sourcing and third party development. From January 2006 to January 2008 he was Head, Global Sourcing Office and since January 2008 Dr. Chandrashekar Nimkar is Head of Technical Competency
Centre – QA at Sandoz Private Limited, India. Dr. Chandrashekar Nimkar has strong background of working in pharmaceutical industry for more than 19 years in various departments. Dr. Chandrashekar Nimkar holds a Ph.D. degree from University of Mumbai and possess post graduate qualification in management (MBA).

Dr. Nicholas J Murrell, Head of Engineering, Lonza Biologics plc / UK

Presentation
The application of systems design to the development of the concept for the transformation of a biopharmaceutical production facility for 21st century operation and implications for maintenance activities

Personal Information

After achieving a degree and PhD in Biochemical Engineering, Nic worked as a Research Fellow at University College London, leading a team investigating the application of single use technology to Bioprocessing, Nic joined Lonza in 2000 as a process engineer supporting Development Services. He is currently responsible for Engineering, including Maintenance, Facilities & SH&E functions, on the Slough Site.

Fabrice Brion, Directeur, I-care sprl / France

Working Group
Condition Monitoring & Predicitive Maintenance

Michael Elliott, Instrument Plant Lean Leader / Operations, BD Diagnostics / USA

Presentation
How to shift from reactive to proactive maintenance in 90 days using lean and Six Sigma techniques with BD medical’s 10 Step TPM methodology

Personal Information

Michael Elliott is a Certified Lean Leader with BD Diagnostics in Sparks, Maryland. Over his 5 years with the company since graduating from Brigham Young University with a degree in Mechanical Engineering Michael has worked as a New Product Development Engineer at BD’s corporate headquarters in Franklin Lakes, New Jersey, a Production Supervisor and Lean Leader in Columbus, Nebraska, a Manufacturing Engineer in Salt Lake City, Utah, and for two years has led the Continuous Improvement efforts for the BD Diagnostic Instrument Plant in Maryland as a member of the Plant Leadership Team. In addition to leading the Lean and Six Sigma programs for instrument manufacturing, Michael continues to implement Lean initiatives outside of manufacturing to other areas such as at the Customers’ Hospital, in Sales and Technical/Customer Services, within the Supply Chain, and with Sustainability.

Stefan Schäfer, Principal, Kienbaum Management Consultants GmbH

Interactive Evening Session:
A systematic and integrated approach for reaching maintenance excellence

Personal Information

After completing his studies in mechanical engineering followed by an MBA program, Stefan Schäfer worked for more than ten years for suppliers of innovative automation equipment for the chemical, pharmaceutical and food industry. He was responsible for the technical transfer of equipment to the end user and so always in touch with the newest maintenance developments in the various industries. After his move into the consulting business more than six years ago, he was leading various Maintenance / Asset Management programs. Since three years, Stefan Schäfer is responsible for the functional competency Asset Management of Kienbaum Management Consultants.

Lorcan O'Toole, Reliability & Maintenance Lead, Genzyme Ireland Ltd

Presentation
Genzyme's Asset Care Excellence Program (ACE) - Improving asset performance with a TPM approach in a sterile fill finish facility

Personal Information

Lorcan O’Toole is a professional engineer with almost 20 years experience within the pharmaceutical manufacturing industry. Qualified with a BSc in Electrical Engineering with an MSc in Manufacturing Engineering, Lorcan has worked across a number of pharmaceutical platforms in various different engineering disciplines including validation, automation, projects and maintenance. An engineering manager for ten years Lorcan is now responsible for maintenance at Genzyme’s sterile fill finish facility in Waterford, Ireland. Lorcan is also a member of Genzyme’s corporate ACE (Asset Care Excellence) steering committee charged with improving asset performance across Genzyme’s global manufacturing facilities.

Gianni Macchi, Maintenance Process Team Leader, Eli Lilly Italia SpA.

Presentation
Risk Based Maintenance & RCM in a large capital project

Personal Information

Gianni Macchi is Maintenance Process Team Leader at Eli Lilly Italia SpA. After his studying he joined Lilly Pharma in 1993 where he was working as a Validation Technician. After changing his role into a process control representative in 1994, Gianni Macchi joined the change control team in 1996. In 1997 he becomes a change control senior technician. From 1998 to 2000 he was responsible for maintenance issues as the maintenance services supervisor. From 2000 to 2009 Gianni Macchi worked in the facility Team, lasting responsible as a facility services Team Leader. From April 2009 till today he is as a Maintenance Process Team Leader responsible for maintenance projects at Eli Lilly Italia SpA.

Dr. Ralf Smounig, Director QA, ROCHE Diagnostics Graz GmbH

Presentation
Preparation and handling of FDA-inspections with focus on embedding of processes in an overall maintenance strategy and test tool interval dynamisation

Personal Information

Studied chemistry at the University of Graz. During his tenure at F. Hoffmann-La Roche AG Basel, he was responsible for the analysis and the GMP compliance of pharmaceutical drug product and drug substance development. Since 2003 he has been responsible for the development of Quality Systems and Regulatory Compliance in the Compliance-Initiative for Roche Diagnostics Graz. He is author and co-author of divisional standards and business area guidelines. In addition, he initiates several group-wide initiatives tools such as global training and harmonization activities, validation & QC harmonization, work-flow and supplier audits. Actually Dr. Ralf Smounig is heading as the Global Business Process Owner the Dia-LIMS stability section as well as the Quality Assurance department at Roche Graz.

Frederico França Giunchetti, Head of Engineering, Sandoz do Brasil Industria Farmaceutica Ltda. / Brasil

Presentation
Increasing the OEE in a Pharmaceutical site through methodologies
implementation and a systematic approach

Personal Information

Frederico França Giunchetti graduated in Electrical Engineering and post-graduated and Master of Science and is currently in the role of the Engineering Head of solids production at the Sandoz site in Cambé, Brazil. Frederico França Giunchetti is well experienced in Process Improvement and Maintenance inside Sandoz and Novartis and in former functions. Previous to this he earned experience in the areas of Projects, Maintenance, TPM, and Manufacturing in a multinational company of the food business. (Unilever) He
is managing engineering projects that doubled the Manufacturing and Packaging capacities of Sandoz solids production site, involving investments of around $5,5 million. Frederico França Giunchetti is mainly focussed on methodology implementation regarding productivity, continuous improvement and operational loss reduction.

Séamus Enright, Plant Manager, UCB group, Shannon / UK

Presentation
Operational excellence and value stream mapping in maintenance activities

Personal Information

Séamus Enright is an Industrial Chemist who specializes in process scale-up and pharmaceutical API management. Having worked in two large pharmaceutical companies prior to joining Schwarz Pharma Limited in 2000, he has a strong understanding of what it takes to develop a new chemical entity through to
production. He has scaled up many commercial API products in a multi-purpose facility during his initial six years in SP Ltd. Since taking over the position of SP1 Plant Manager in 2006 Séamus has played a key role in the recent site development project and SP1 facility upgrade. He successfully project managed an interdepartmental, multi disciplinary team that integrated a new eight step synthetic process into all site systems including the SP1 plant, where he has overall responsibility.

Dr. Falk Klar, Chief Compliance Officer, IDT Biologika / Germany

Presentation
A systematic approach for achieving operational excellence in the pharmaceutical industry

Personal Information

After completing his studies in physics and obtaining the PhD, Mr. Falk Klar started his industrial career in a medical device company. Between 1995 and 1999 he was responsible for organisation, conducting and data evaluation of preclinical and clinical studies. During that time he attended a qualification programme to become a Quality Manager. In 1999 he joined an international Contract Research Organisation as Project Manager responsible for conducting clinical trials in phases I to IV. Between 2002 and 2009 Dr. Klar was employed as Head of Quality Assurance of Biomeva GmbH, a biotech Contract Manufacturing Organisation producing APIs. He gained comprehensive experience in the wide spectra of GMP quality management including validation of manufacturing processes and computerised systems. In 2010 Dr. Klar joined IDT Biologika GmbH, a global supplier to the pharmaceutical and biotechnology industry. In his recent position as Chief Compliance Officer he is responsible for all quality assurance and compliance aspects in the branches human vaccines,
contract manufacturing of biopharmaceuticals and animal health.

Ferruccio Migliorini, Senior Manager Engineering /Maintenance /HSE, Eli Lilly Italia SpA

Presentation
Risk Based Maintenance & RCM in a large capital project

Personal Information

Has been studyieng till 1992 mechanical engineering at Facoltà Ingegneria, Università di Firenze. Since July 1997 he holds a PhD in Energy Engineering at Dip. Energetica, Facoltà Ingegneria, Università di Firenze. In the same year he started his career as permanent employee as Project Engineering Associate (B2) by Manufacturing Division of  Eli Lilly Italia SpA, In 1999 he changed his role into a Project Engineering Head (B2 with Supervision) and in April 2000 into a Project Engineering Team Leader (B1). Since 2005 he is responsible for Engineering, Maintenance, Health & Safety as a Senior Manager (Director). Regarding his functional role Ferruccio Migliorini has experiences in large capital projects, in supervision for civil structures, utilities, equipment in line with GEP, GMP, Regulatory (FDA and EMEA) as well as HSE requirements, commissioning and qualification of utilities and equipment, based on GMP regulatory requirements and in equipment and utilities stabilization and optimization in powder filling/finishing processes.

Fabio Oro, Principal, Kienbaum Management Consultants GmbH

Chair & Moderation

Personal Information

Fabio Oro graduated in Chemical Engineering in 1996. He joined Lonza in 1997 and worked there in various positions. After several years in R&D, Fabio was assigned as plant manager responsible for the start-up of a new production plant in Visp, Switzerland. After a job rotation as process development manager in Los Angeles, USA, he then took over the role as production manager being responsible for technology transfers and production of pharmaceutical API’s and intermediates. In 2005 he successfully achieved an executive MBA from the University of St.Gallen. The same year Fabio moved to Basel, Switzerland where he was responsible for various strategic initiatives like the start-up of a new production organization in Nansha, China as well as an implementation of a new portfolio management process/system within Lonza Exclusive Synthesis. In 2006 he became the global head of Operational Excellence, being responsible for implementing of OE within the Exclusive Synthesis Sector in Lonza. Since June 2010 Fabio Oro is working as Principal for Kienbaum Management Consultants GmbH.

Dr. Ingrid Bause, Head Quality Engineering, Compliance Quality, Novartis Behring/ Deutschland/ Germany

Presentation
Human Error Prevention & Root Cause Management in Pharmaceutical Operations

Personal Information

After 10 years of experience in research and teaching at different universities in the USA (Wisconsin/ Madison) and Germany (Georg-August-Universität Göttingen, Freie Universität Berlin) within the area of veterinary immunology/ - virology transition into Pharma Industry was performed.  Five years of experience in regulatory affairs being accountable for the submission and processing of applications for marketing authorization within the EU, East European countries, the USA as well as Japan (Company: Hoechst Roussel Vet.  Products: Veterinary Vaccines of small and large animals).  In the year 2000 a leading position in Quality/ Batch Disposition was accepted taking the function as a QP/ Release Responsible Person (Company: Chiron, since 2006 Novartis Vaccines & Diagnostics. Products: Human viral and bacterial vaccines).  Currently, the super ordinate position as Head Quality Engineering, QA Compliance is being held.

Mark Haarman, Managing Partner, Mainnovation

Presentation
Building a Winning Maintenance Strategy with VDM

Personal Information

Mark Haarman holds a master degree in mechanical engineering (specialization maintenance management) from the Delft University of Technology and an MBA degree from the Erasmus University of Rotterdam, both in the Netherlands.He went on to work for the Rotterdam public transport company RET as an internal maintenance consultant. He subsequently headed the Evaluation Department at Rijkswerf (the maintenance and repair yard of the Royal Dutch Navy). In 1995, he moved to Ernst & Young Consulting, where he set up and led the Maintenance & Service Consulting Practice.
In 2000 Mark established Mainnovation. The company is now one of the leading maintenance consultancies in the Benelux and the inventor of Value Driven Maintenance^®. VDM^® is a methodology for developing maintenance organizations in such a way that they create demonstrable value for a company.
In the course of his career, Mark has become a maintenance expert with a wide array of expertise. He has acquired considerable knowledge and experience of various maintenance methods (including RCM and TPM), benchmarking and optimizing maintenance organizations and selecting and implementing Enterprise Asset management (EAM) systems. He was involved in maintenance and asset management projects in Aerospace, Chemical, Food & Drinks, Oil & Gas, Power, Rail and Pharmaceutical industries.
He contributes actively to the development of his field of specialization through market research, published articles, seminars and training courses. Moreover, he is a frequently invited keynote speaker at leading international conferences. He is a former chairman of the Dutch Maintenance Association (NVDO) and the author of a book entitled "Value Driven Maintenance®, New faith in maintenance".

Andrew Whytock, Industry Manager, MES Centre of Excellence for Life Science, Siemens AG

Working Group 2
MES & Statistic Process Control in Pharmaceutical Operations

Personal Information

Andrew Whytock is currently Industry Manager at the Siemens MES Center of Excellence for Life Sciences headquartered in Toulouse, France. With extensive commercial and project management experience of complex IT and manufacturing solutions in multiple industries and across different continents, his current role is to support the Siemens organsiation and customers with MES initiatives in the Life Sciences industry. A former employee of Elan Software, Andrew holds both a UK honours degree and is a graduate in international business from the Bordeaux Ecole de Management.

Robert Harrison, Industry Manager Pharmaceutical, COPA-DATA GmbH / Austria

Presentation
Leverage production automation through a knowledge based workforce

Personal Information

Robert Harrison started his career as an Industrial Engineer at Michelin Tyres PLC Burnley UK, responsible for plant infrastructure & design. In 2000 he changed from industry to research at the Institut Laue Langevin (ILL) Grenoble France, where he was responsible for the evolution of cryostat environment control systems on scientific instruments. From 2004 Robert worked at CERN European Organization for Nuclear Research, Geneva Switzerland. Contributing to the LHC (Large Hadron Collider) project, responsible for the detailed PLC design, testing & commissioning of Super Conduction Magnet protection systems. Regaining his industrial career in 2007 as an independent consultant Project Manager, taking the responsibility for a pharmaceutical building automation system (HVAC & Process) at Pfizer Strängnäs Sweden. In 2008 Robert Harrison continued as a consult with the company EPLAN Software & Service GmbH, taking his knowledge of engineering design experience to benefit customer evolution. Since 2009 Robert Harrison is working with COPA-DATA GmbH responsible for directing & coordinating their pharmaceutical activities to deliver the optimal performance to customers, and push the products of COPA-Data to leading edge solutions.

Dr. Joachim Reineck, Head of Manufacturing, Merz Group Services / Germany

Working Group
How to increase OEE & operational excellence