Imge Yilmaz

Responsible for the implementation of a Manufacturing Execution System (MES) and digital manufacturing solutions within cell therapy production (Operational Excellence ATMPs) and rollout of AI solutions with AI Governance

Key Responsibility: Manage computer system validation (CSV) strategies. Achievements: Created an AI validation framework in a GMP environment. Led network security and OT projects from QA. Optimized validation workflows- digitalized process controls Planned and developed validation strategies for cloud applications and data migration, ensuring data integrity. Validated critical infrastructures. Contributed as an author to the new ISPE guideline (Sections: IT/OT Cybersecurity, Cloud implementations in GMP).

Developed and fine-tuned an AI model using Python and TensorFlow to classify microscopy images of cell-based medicinal products, achieving 96% validation accuracy under GMP-compliant research protocols.

Using tools to interpret nanobody datasets, paying particular attention to trends and patterns that could be valuable for diagnostic and predictive analytics efforts. Using coding languages like Python (Pandas, NumPy, Seaborn, Matplotlib libraries) and R language to analyze data, check results' reasonability, and implement ML solutions (Scikit-learn). Reporting results to supervisors.