Parth Shah

Sr Project Engineer i @Project Farma Pf

Indianapolis, IN, US

Engineering Support for commissioning and qualification of Isolators and Production Equipment for Radioligand Therapy manufacturing sites• Coordinates with client stakeholders and project teams to facilitate alignment on project status, needs, scope, and schedule.• Drafted and executed validation documents through the qualification lifecycle including C&Q Plans, User Requirement Specifications, Installation, Operational, and Process Verifications, and Qualification Summary Reports• Managed qualification non-conformances (NCs) including Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA) Management for multiple Production Isolator and Equipment Systems