Validation Expertise, IVD-Specific Knowledge, Medical Device Compliance, Lean and Continuous Improvement, Advanced Manufacturing Engineering

manufacturing processes , Six Sigma, LEAN methods, Ms Office Suite, Statistical Techniques, CAD, FDA regulations, project management tools

risk assessments, cobots, validation documents, comparability study, digitalized and automated capabilities, cloud systems, automation recipes, Process Validation, biologics process line, deltav, Single Use Systems, Technology Transfer, electronic batch records