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With 25 years of experience and numerous roles Carsten is a true master of digital manufacturing in pharma and biotech industries. He has worked in depth with all major production modalities and application types. With a background in biochemical engineering and software development he has been leading development of advanced automation and PAT solutions beforeRead more

Steven Barash is a dynamic manufacturing information systems thought leader spearheading digital manufacturing initiatives at L7 Informatics. Steven holds an established software implementation portfolio of regulated technology solutions in the cell and gene therapy manufacturing industry. Steven is committed to end-to-end automation of complex cell gene manufacturing operations to deliver personalized treatments to patients. HeRead more

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 manufacturingRead more

My name is Thomas Steiner and for the past 9 years I am acting as the Global Strategic Account Director for several major global Life Science companies. I am based at the Emerson Process Management Europe – HQ in Baar/Switzerland. 1993 after graduating as Mechanical Engineer (Bachelor of Science) specialized in Thermal Dynamics, I workedRead more

Ms. Guven over 20 years of experience in IT Quality and Computer Systems Validation in Pharmaceutical Industry at Apotex including: Process / Continuous Improvement experience, superior knowledge on FDA 21 CFR Part 11 Electronic Records and Electronic Signatures and Data integrity remediation. Apotex Inc. is a proudly Canadian, global pharmaceutical company that produces high-quality, affordableRead more

Sam, originally from Belgium and currently residing in Marburg, Germany, graduated as an Engineer with an additional Master’s degree in General Management from Vlerick Business School. Throughout his career, he has been involved in the Life Science industry, focusing on large-scale digital transformation projects. These projects included significant mergers and acquisitions. Following his consulting work,Read more

1. Under the defined US FDA Standard Facility URS, Preparing Project Feasibility Report depending on Capex, Opex and Sales Forecast. 2. Designing the Smart Pharma Factory Project Under the Umbrella of Pharma 4.0 considering eQMS, LIMS, MES, eDMS, eTMS, BEMS etc. ensuring the Data Integrity by Design and Green Factory by Design. 3. Ensuring CivilRead more

I’m an integration engineer in the automation department of Johnson & Johnson in Schaffhausen, Switzerland, who is responsible for interfacing level 2 equipments with MES. Before I joined Johnson & Johnson I worked for a peptide manufacturing company and was among others responsible for the MES implementation as a project manager and afterwards for theRead more

Rebecca Nørgaard has been working at Novo Nordisk since 2009 as a Solution Architect for the organization’s largest-ever IT program, implementing SAP and PAS-X MES systems in 30+ production sites. Presently, she holds the position of System Architect in the Novo Nordisk MES programme CoE, where she is responsible for the scoping and harmonization ofRead more

Industrial Engineer Projektmanager Berliner Hochschule für Technik, M.A. Industrial Engineer Mechanical Engineering Berliner Hochschule für Technik, B.E. 2023 – Director Pharmaceuticals & Process Manufacturing at we.CONECT Global Leaders GmbH. 2022 – 2023, Projektmanager at Mercedes Benz AG 2021 – 2022, administrative manager at Berliner S-Bahn GmbHRead more