Melody Ezgi̇ Gülcan

About Melody Ezgi̇ Gülcan

Accomplished Project Manager/Lead with over 20 years of exemplary performance in the…

Experience

1. Deputy Director, Engineering Projects

   Sanofi

   Sep 2020 — Present

   Engineering Workstream Lead for projects such as a new facility design for a new pandemic flu product with a Combo Filling Line; a new Syringe Inspection Machine replacement project; Site environmental monitoring system replacement and small projects supporting FFIP (Formulation, Filling, Inspection and Packaging) of Swiftwater Site. • Participate in the overall project teams as the engineering lead. These teams include different stakeholders, typically Manufacturing, QV, Mtech, ITS, Compliance. • Manage multiple teams simultaneously. Teams of 10-15 SME’s (Subject Matter Experts) from process to automation engineering; vendor [Architectural and Engineering(A&E) firm/ Equipment Vendors] teams. • Responsibilities extend managing the project until end of commissioning and qualification (C&Q) • Collaborate with different user groups of Sanofi such as HSE, Operations, Quality, Mtech, Procurement to understand how the equipment and the facility will be utilized as well as the project timeline(s) and individual group\'s deliverables. • Collaborate with global engineering group to standardize equipment and facility design between different Sanofi sites. There\'s emphasis on new technology and design requirements launched globally such as utilizing robots/cobots for loading/unloading or Carbon-Neutral design for new facilities. • Attend/present to different Sanofi groups and government agencies/groups such as BARDA if needed. • Coordinated procurement process with both local and global procurement groups for key equipment/services such as the combo filling line/isolator/e-beam, High Speed Inspection Machines, Engineering Services, Construction Management Services…etc

Education

• Bogazici University, Istanbul

  B.S, Chemical Engineering

• Ataturk Fen Lisesi

  High School, Advanced chemistry,Biology, advanced physics, arithmetics, calculus, geometry, trigonometry,

• Technical institue of America

  PMP prep, Project Management

• The City College of New York

  M.S, Chemical Engineering

Skills

• Validation
• Strategic Planning
• Analysis
• Six Sigma
• Biotechnology
• Gmp
• Capa
• Fda
• R&D
• Quality Assurance
• Management
• Research
• Quality Control
• Leadership
• Project Management
• Chemical Engineering
• Quality System
• Project Planning
• Lean Manufacturing
• Pharmaceutical Industry
• Cleaning Validation
• Cross-Functional Team Leadership
• Testing
• Engineering
• Manufacturing
• Pharmaceutics
• Sop
• V&V
• Change Control
• Stem Cell Research
• 21 Cfr Part 11