Collaborate with Quality Control, Quality Assurance, Operations, Engineering, Customer Service, Maintenance, and R&D teams to design and plan validation activities, write protocols, execute tests, document results, prepare reports, and secure required approvals for all validation activities, including product processing, product packaging, and utilities. Strong problem-solving skills and advanced statistical analysis capabilities using quality engineering tools such as fishbone diagrams, Pareto charts, cause-and-effect matrices, hypothesis testing, control charts, ANOVA, Design of Experiments (DOE), sampling methods, and process capability analysis.