Adrian Verdin

WORK HISTORY

EDUCATION

ABOUT ADRIAN VERDIN

5+ yrs experience in Medical Device Engineering, Pharmaceutical Processing, and Combination Products. I specialize in project management, product lifecycle management, process development, and process optimization.SKILLS-3D Modeling and Drawings: Proficient in SolidWorks, Creo Pro-E, ANSYS Fluent, Autodesk-CIP: Experienced in designing and implementing Clean-In-Place systems to maintain the cleanliness and sterility of production equipment-Design History File: Skilled at authoring the documentation that outline the design and development of a medical device-Device Master Record: Expert at procuring all specifications, engineering drawings, BOMs, and maintenance procedures required to consistently build a medical device-Design Validation and Verification: Proficient in conducting thorough validations & verifications to ensure product safety and efficacy-ERP Management: Skilled in managing Enterprise Resource Planning (ERP) systems to streamline production-Equipment Qualifications: Skilled at conducting Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Process Performance Qualification (PPQ) to ensure compliance with ISO 13485 for automated final assembly equipment, packaging equipment, inkjet printing lines, and thermal transfer printing lines-Industrial Water Systems: Proficient in managing Water for Injection (WFI) systems to ensure compliance with pharmaceutical standards-Piping & Instrumentation Diagrams (P & ID): Skilled in creating and interpreting Piping & Instrumentation Diagrams (P & ID) for accurate process control-Product Lifecycle Management: Adept at managing full Product Lifecycle (LCM) for medical devices, from concept and design through development, validation, commercial launch, and post-market support, ensuring compliance with FDA standards & ISO standards-Process Validations: Expert at establishing objective evidence to prove that a manufacturing process is repeatable and reproducible such that it consistently produces a medical device that meets all specifications as specified in the Device Master Record-Risk Analysis: Adept at performing risk analysis using Failure Modes and Effects Analysis (FMEA) methodologies to identify and mitigate potential issues-Root Cause Investigations: Experienced in conducting root cause investigations to identify and resolve nonconformances -Sterilization Validations: Experienced in performing sterilization validations, including Partial Cycle, Half Cycle, Full Cycle, & Residuals testing, to ensure product sterility