Urvi Shah

About Urvi Shah

Senior validation Engineer/ Validation Manager with 11 years of experience in FDA and ISO regulated Life Science Companies, Project Management, Validation Engineering, Process Control, Process Engineering, Equipment Validation, Fill Finish Packaging, Finish Good Packaging -Primary and Secondary Packaging, Facility Qualification, Utility Qualification, preparation of SOP(Standard Operating Procedure), Change Controls, CAPAs, NOIs following cGMP guidelines including Installation Qualification, Operational Qualification and Performance Qualification IQ/OQ/PQSpecialized in qualification (IQ/OQ/PQ) of pharmaceuticals equipment.Skills and Core Competencies- Project Management- Packaging and Supply Chain Validation- Process Development and Continuous Process Improvement- Project Management- Data Analysis and Statistical Methods- Root Cause Analysis- Strong Leadership skill and Team Player- Manufacturing Strategy and Planning- Equipment /Process Validation- Strong communication, organizational, Interpersonal and Teamwork skill- Experience in Technical writing and Documentation in compliance with FDA and cGMP- Knowledge of Six sigma, Lean Manufacturing, root cause analysis, Continuous improvement, QMS and other manufacturing tactics.

Experience

1. Sr Validation Engineer-cqv Packaging & Supply Chain

   Alnylam Pharmaceuticals

   Jun 2021 — Present · Cambridge, MA, US

   Responsible for planning and implementing multiple concurrent projects involving Supply Chain, Packaging validation, Equipment Validation, RevalidationManaged he New Product introduction roadmap ensuring alignment with pipeline portfolio objective an long term business goal with Global supply chainPartner with Supply chain and CMOS to ensure validation activities ( shipping, pack/label) are conducted as per Alnylam requirements.Manage validation lifecycle activities to maintain the validated state ( qualification, periodic review).Provide validation support in deviation investigation and change control.Design and execute validation studies at company site that are compliant with the established procedures and aligned with the industry best practices.

Education

• Dharamsinh Desai University

  Bachelor in Chemical Engineering, Chemical Engineering

  2009 — 2013

• Lamar University

  Master of Engineering (M.Eng.), Chemical Engineering

  2015 — 2016