Shubham Sandilya

Shubham Sandilya India Phone:- Email:- Professional Summary Experienced Medical Device Validation Engineer with 5 years of expertise in machine validation, quality assurance, and regulatory compliance. Proficient in GMP, FDA, GDP, project management, and data analysis. Adept at ensuring compliance with ISO 13485 and Six Sigma methodologies. Proven track record in leading validation projects across diverse medical manufacturing processes. Skills & Expertise Medical Device Validation & Quality Assurance GMP, FDA, GDP Compliance Project Management (PMP Certified) Data Analysis & Process Improvement ISO 13485 & Six Sigma Risk Assessment & CAPA Implementation Injection Molding, Blow Molding & Extrusion Blow Molding Equipment & Process Validation Manufacturing & Assembly Automation Work Experience Validation Engineer BBRAUN & BD, India Conducted validation and qualification of medical device manufacturing equipment, ensuring regulatory compliance. Led process validation for Injection Molding, Blow Molding, and Extrusion Blow Molding machines. Developed and executed IQ, OQ, PQ protocols for various medical device manufacturing systems. Managed risk assessments, CAPA, and change control processes to improve production efficiency. Collaborated with cross-functional teams to ensure smooth project execution and compliance with ISO 13485 & FDA standards. Education Executive MBA, Indian Institute of Management (IIM) Calcutta Bachelor’s Degree, Jawaharlal Nehru Technological University, Hyderabad (JNTUH) Certifications Six Sigma (Green Belt) ISO 13485 – Medical Devices Quality Management System PMP – Project Management Professional Projects Handled Injection Molding Machine Validation – Ensured process reliability and compliance with GMP standards. Blow Molding Machine Validation – Led qualification protocols to improve process efficiency. Extrusion Blow Molding Machine Validation – Optimized performance and quality assurance. Assembly Machines Validation – Streamlined assembly processes to enhance production output.