Manufacturing and Validation Engineer with 5 years of experience optimizing production processes, reducing costs, and enhancing product quality. Proven ability to implement lean methodologies, improve efficiency, and drive continuous improvement initiatives. Skilled in quality engineering statistical analysis, strategic planning, and compliance with regulatory standards (FDA, DEA, EMA). Experienced in root cause analysis, corrective/preventive actions (CAPA), and failure mode effect analysis (FMEA). Proficient in validation protocols/reports (IQ, OQ, & PQ), configuration management, and test planning. Strong team-oriented skills for participating in complex projects.