Solution Study
Monday, September 22
09:00 AM - 09:30 AM
Live in Berlin
Less Details
Join our experts to leverage decades of Industry 4.0 and Pharma expertise and discover a proven blueprint to transform compliance driven data into a scalable engine of efficiency, innovation, and quality powered by AI through the Model Context Protocol (MCP). Pharma manufacturers generate vast amounts of process data yet unlocking its full potential in real time and across validated systems remains a critical challenge. In this keynote our Pharma 4.0 experts will share an actionable Industrial AI Strategy that modernizes your data infrastructure, connects siloed systems such as EBR, LIMS, PLCs, and SCADA, and enables predictive quality and operational efficiency while maintaining regulatory compliance. You will gain clear guidance on how to unlock the full value of your digital transformation journey through unified data strategies, collaborative governance, modern architectures like the Unified Namespace, and by unleashing the power of MCP to enable AI at scale. In this session, you will learn how to:
With over six years of experience in the biopharmaceutical industry, Jesse Daneels has built a cross-functional career grounded in strong technical expertise. He started as a system engineer, supporting infrastructure and operations in highly regulated GxP environments. He later moved into roles such as Technical Service Owner (TSO), Computerized System Validation (CSV) engineer, and subject matter expert—gaining deep knowledge of compliance, data integrity, and system lifecycle management.
Jesse’s path gradually shifted toward strategic roles, including project manager and business analyst, where he led cross-functional teams and helped translate business needs into technical solutions. His focus has consistently been on delivering validated systems that align operational performance with regulatory requirements.
As a TSO, Jesse has overseen the reliability and continuous improvement of critical IT systems within global operations. He is recognized for his analytical thinking, collaborative mindset, and clear communication.
Jesse is passionate about digital transformation, process optimization, and contributing to innovations that enhance product quality and patient outcomes.
The Pop in Your Job: What drives me most is knowing that the work I do has a real, tangible impact on people’s lives. In the biopharmaceutical industry, every improvement we make—whether in system design, validation, or process optimization—ultimately supports the delivery of safe, high-quality therapies to patients who need them. That’s a powerful motivator.
I love solving complex problems, and working in manufacturing systems allows me to do just that. It’s like putting together a puzzle with high stakes: aligning regulatory requirements, technical constraints, and business objectives to create efficient and compliant solutions. The fact that this puzzle-solving contributes to something as meaningful as patient health makes it deeply rewarding.
I am a Senior Digital Consultant passionate about driving digital transformation in the manufacturing industry. I began my career as a system engineer, working with industrial automation, OT/IT integration, and infrastructure. Over time, I moved into a senior consulting role where I guide manufacturers through complex transformation initiatives that align technology, business objectives, and regulatory requirements.
I help manufacturers solve what I see as high-stakes puzzles—where Unified Namespace architectures, MES and EBR systems, and workflow optimization must all fit together to deliver measurable outcomes.
Notable projects include the deployment of Electronic Batch Record systems that reduced Master Batch Records by 60% and accelerated batch release times by 30%, as well as digital roadmaps that standardized operations across multiple sites. My expertise spans Industry 4.0, Pharma 4.0, MES MOM, and smart manufacturing.
I believe digital transformation isn’t just about efficiency—it’s about revitalizing industries, creating jobs in Europe, and fostering long-term resilience in a rapidly evolving world.