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Session

Tuesday, September 26

04:10 PM - 04:40 PM

Live in Berlin

Less Details

In the Harvesting Session the workshop moderators of the event will summarize the results of their discussions and highlight key findings from the World Cafés.

Speaker

Marianne Hansen

Advanced MES Analyst MIT-MES, Novo Nordisk A/S

Worked for Novo Nordisk for 7 years initially as Filling Process supporter and Local PAS-X super user and designer. From 2021 as Advanced MES analyst in Global Novo Nordisk MES agile program. currently part of the central PAS-X CORE 3.3. project with focus on migration and deployment.

Tina Walther

Advanced MES Analyst, Novo Nordisk A/S

1999-2004 Novo Nordisk, QC-lab Laboratory technician, Chemical and biological analysis
2004-2007 Novo Nordisk, Supporter Formulation of insulin products
2007-2010 Novo Nordisk, Special technician, Formulation of insulin products
2011-2012 Novo Nordisk, Special technician, Project coordinator, work package owner for formulation of insulin products
2012-2018 Novo Nordisk, Professional (formulation) Project manager, work package owner for formulation of hGH and hemophilia products.
2018- Novo Nordisk, Advanced MES analyst (PAS-X) in Global Novo Nordisk MES agile program.

Currently part of the Fill & Finish expansions project with focus on standardized and harmonized GMBRs for multiple site deployment.

Oliver Frager

CTO, ROTZINGER PharmaPack

Oliver Frager is an expert with more than 30 years of extensive experience in innovation management and mechatronic engineering in the area of digitalization, software systems, modular machinery, robotics and automation systems for production, inspection and packaging in various industries such as pharmaceutical, medical devices, chemical, automotive and energy production. In various management positions in companies like Rotzinger Group and Rotzinger PharmaPack GmbH, Bosch Packaging, Syntegon Technologies, teamtechnik Maschinen und Anlagen GmbH, AUTEFA and Telerobot Engineering Oliver Frager held responsibilities for innovation and R&D in the area of MES and track & trace systems for pharmaceutic and chemical industry, medical device production, automotive industry. Oliver Frager responsibilities covers areas like inspection machinery for pharmaceutic and chemical production, modular assembly and testing machinery, packaging machinery for sustainable packaging solutions, robotics and telerobotics as well as, machinery and robot control systems, HMI, industrial communication systems and simulation systems. Oliver Frager has a proven global experience in production ramp-up of complex production and packaging plant machinery, automation and software systems. Oliver Frager was member and working group leader in several standardization working groups (ISO, IEC, DIN, VDI) for topics like MES systems, machinery programming languages and machinery safety. Oliver Frager holds a Dipl.-Ing. and Dr.-Ing. (PhD) degree in engineering and computer science from University of Stuttgart, Germany.

- to make our world a better place with our contribution to ensuring the health and nutrition of the global population and our contribution to environmental protection with sustainable packaging solutions
- early creation, application and combining of innovations in areas such as digitization, automation and sustainability to achieve and ensure this goal fast and efficiently for more and more people.

Oliver Frager

CTO, ROTZINGER PharmaPack

Oliver Frager is an expert with more than 30 years of extensive experience in innovation management and mechatronic engineering in the area of digitalization, software systems, modular machinery, robotics and automation systems for production, inspection and packaging in various industries such as pharmaceutical, medical devices, chemical, automotive and energy production. In various management positions in companies like Rotzinger Group and Rotzinger PharmaPack GmbH, Bosch Packaging, Syntegon Technologies, teamtechnik Maschinen und Anlagen GmbH, AUTEFA and Telerobot Engineering Oliver Frager held responsibilities for innovation and R&D in the area of MES and track & trace systems for pharmaceutic and chemical industry, medical device production, automotive industry. Oliver Frager responsibilities covers areas like inspection machinery for pharmaceutic and chemical production, modular assembly and testing machinery, packaging machinery for sustainable packaging solutions, robotics and telerobotics as well as, machinery and robot control systems, HMI, industrial communication systems and simulation systems. Oliver Frager has a proven global experience in production ramp-up of complex production and packaging plant machinery, automation and software systems. Oliver Frager was member and working group leader in several standardization working groups (ISO, IEC, DIN, VDI) for topics like MES systems, machinery programming languages and machinery safety. Oliver Frager holds a Dipl.-Ing. and Dr.-Ing. (PhD) degree in engineering and computer science from University of Stuttgart, Germany.

- to make our world a better place with our contribution to ensuring the health and nutrition of the global population and our contribution to environmental protection with sustainable packaging solutions
- early creation, application and combining of innovations in areas such as digitization, automation and sustainability to achieve and ensure this goal fast and efficiently for more and more people.

Eric Chinchilla

IT Director of Global Process Integration & IT Finance, KENVUE

Eric Chinchilla is IT Director of Global Process Integration and IT Finance at J&J enterprise platforms, applications and big data strategies. He has been with J&J since 1994, with his SAP experience beginning in 2004. His hold a baccalaureate in accounting and has been part of J&J finance, or IT supporting finance, through 2012, holding roles in: supply chain finance; financial reporting, planning and analysis; and business intelligence (OLAP). His prior roles have spanned all business processes (e.g. plan, source, make, quality, deliver, and finance), as well as driving system architectures and landscapes to support the business.

Kevin Feeney

MES Systems Administrator, Lonza Netherlands

IT/OT Business Systems Specialist

Supporting Laboratory (LIMS) & Manufacturing (MES, Track & Trace, Automation) Software and Systems in GxP regulated environments.
Experienced Data Integrity Specialist.
Incident & Problem Management
Life-Cycle Management
Software Validation, Configuration & Deployment. (Gamp5, CSV)
Systems Maintenance

I have a strong background in Support and Administration of Regulated Systems in GxP manufacturing including Projects, Upgrades, Critical Incident Management and security patching.
Additionally, I have Knowledge & Experience in Data Integrity and Implementing Data Integrity approaches on a site wide level.

I have experience in following GxP, Gamp5 & CSV procedures to ensure all systems are implemented in compliance with current regulatory requirements. I am used to working as part of a cross-functional teams to help ensure the delivery of projects and support the day-to day administration of Global & Site systems.
I have experience in drafting, devloping and excicuting various documentation, including SOP’s, Work Instructions, IQ/OQ/PQ & Knowledge Articles (KB’s). Additionaly I have experience in drafting, delivering and implementing site training.

I am currently working as MES Systems Administrator (MODA-ES) for Lonza NL

Keith Bowen

LES/MES Advocate, Apprentice.io

With 24 years of experience in the Life Science industry, Keith is well respected for his knowledge and experience with pharma systems and software development, solution design, system integration, implementations, and support services for both large and small projects.
He has worked with many of the Top 10 Pharma, Biotech and Medical Device companies. Today, he is an MES/LES Advocate at Apprentice.io and works primarily with new customer engagement, interfacing between sales, product and marketing.

Daniel Coudriet

Digital Manufacturing Director, Capgemini Engineering

Experienced Head Of Manufacturing Analytics Consulting passionate about designing and scaling-up smarter, more sustainable, human centric operations leveraging digital technologies, with a demonstrated history of successful Digital Manufacturing Transformation endeavors across multiple industries, from Automotive to Life Sciences to Manufacturing.

Arnaud Sebert

Lead Engineer Manufacturing operations, Capgemini Engineering

Arnaud leads industrial performance and digitization programs at Capgemini Engineering’s Compliance & Performance – Smart Factory in LifeSciences teams. He is an Industry and Operational Excellence expert. Prior to Capgemini, Arnaud held leadership positions into Pharmaceutical Manufacturing and Operations. He is based in Lyon – France.

Laurent Samot

Smart Factory, Capgemini Engineering

As global head of the COE Smart Factory, Laurent is working with our digital manufacturing practices to implement the fourth industrial revolution: Industry 4.0

Esther Henoch

Enterprise Software Sales Executive, Rockwell Automation GmbH

Esther Henoch is a Sales Executive supporting Life Science manufacturing companies on their digital transformation journey. She is based in Germany and has more than 20 years of experience delivering software solutions, covering MES, Serialization, IoT, Augmented Reality, Analytics, EAM and Connectivity. The approach of the Information Solutions team is to help identify the main challenges faced by manufacturers, looking at quality, maintenance, operations, production control, inventory management and supply chain. They focus on use cases with data-driven insights that will bring the most value to manufacturers and help to maximize productivity, outperform quality standards and accelerate speed to market.

Company

Novo Nordisk A/S

We are a global healthcare company, founded in 1923 and headquartered just outside Copenhagen, Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity, and rare blood and rare endocrine diseases. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure the diseases we treat. We employ more than 55,000 people in 80 offices around the world, and market our products in 170 countries.

KENVUE

Kenvue (a spinoff of J&J consumer/ over-the-counter brands) is an American multinational corporation established in 2023 that develops consumer packaged goods. It has just listed on the NYSE in May 2023 and is in the process of separating from Johnson & Johnson in all aspects.

Lonza Netherlands

At Lonza, we enable #AHealthierWorld by supporting our healthcare customers on the path to commercialization. Our community of 16,000 talented employees work across a global network of more than 30 sites to deliver for our customers across the pharma, biotech and nutrition markets. By combining technological insight with world-class manufacturing, scientific expertise and process excellence, we help our customers to deliver new and innovative medicines that help treat a wide range of diseases. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising commitment and ideas that help our customers to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. Our work makes #AMeaningfulDifference.

ROTZINGER PharmaPack

Rotzinger PharmaPack is the competence center for pharmaceutical packaging within the Rotzinger Group. Its core business is solutions for the packaging and cartoning of solid and liquid end products as well as track & trace solutions for serialization and aggregation. Most of Rotzinger PharmaPack's customers are at home in the pharmaceutical industry. They primarily pack bottles, vials, ampoules, jars, syringes, auto-injectors, pouches and blisters. Rotzinger PharmaPack offers both individual machines and complete systems as well as services and MES software. Rotzinger PharmaPack has been part of the Rotzinger Group since 2021. The company has its headquarters in Waiblingen near Stuttgart and employs around 110 highly motivated people.

Apprentice.io

Apprentice helps life science manufacturers get treatments to patients faster by providing one platform to turn molecules into medicine. Our Tempo Manufacturing Cloud lets you scale up and out with unprecedented speed and accuracy. From preclinical benchtop to large-scale commercial manufacturing, Tempo keeps your global teams connected, empowered, and in sync. With $140M in funding, a 12x growth rate, and 512% net customer retention, Apprentice is a trusted partner to modernize your operations and change the way drugs are made in your facility. Learn how leading companies like Catalent, Synthego, and Bristol Myers Squibb are using Tempo to scale from drug discovery to patient delivery faster at www.apprentice.io.

Capgemini Engineering

Capgemini Is a global leader inppartnering with companie to transform and manage their business by harnessing the power of technology. The Group is guided everyday by its purpose of unleashing human energy through technology for an inclusive and sustainable future. It is a responsible and diverse organization of over 350,000 team members in more than 50 countries. With its strong 55 year heritage and deep industry expertise, Capgmini is trusted by its clients to address the entire beadth of their business needs, from strategy and deign to operations, flueled by the fast evolving and innovative world of cloud, data AI, connectivity, software, digital engineering and platforms. The Group reported in 2021 global revenues of €18 billion.

Rockwell Automation GmbH

Rockwell Automation is the largest company in the world that is dedicated to industrial automation and information. Across the globe, our flagship Allen‑Bradley® and FactoryTalk® product brands are recognized for excellence. Our keen focus on technology innovation, domain expertise, and integrity and corporate responsibility fuels our success.

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