Senior MES validation technician and CSV Engineer with over 10+ years of Quality and 4+ Validation experience in the medical devices and manufacturing industries. Proven expertise in MES modeling, CSV lifecycle, protocol development (IQs, PQs, TR executions), and user training. ISO 9001 certified with a Lean Six Sigma Green Belt, recognized for high attention to detail, urgency, and ability to lead projects to successful completion under pressure.
Results-driven consultant with expertise in computer system validation. Strong background in ensuring compliance with regulatory standards and optimizing system performance. Known for effective team collaboration, adaptability, and delivering high-quality outcomes. Skilled in risk assessment, validation protocols, and quality assurance. Trusted to meet changing needs and exceed expectations.