Melissa Balmer

About Melissa Balmer

Technical Engineering Professional with more than 25 years experience in the design and operational support of facilities used for the production of biologics and/or vaccines. Experience with both greenfield and retrofit projects with an installed cost range of $50M to >$200M. Support of all project phases, from Concept Design through Commissioning & Qualification, Start-up and licensed Production Support. Firsthand experience understanding both the owner\'s need for reliable, maintainable, and licensable facilities and the engineering / design organization\'s mandate to deliver value-added work product within schedule and budget. Demonstrated experience managing small to medium size engineering / cross-functional teams. Member of ASME BioProcessing Equipment Standards committee for more than 15 years; Vice-chair of Systems Design subcommittee.

Experience

1. Associate Director, Engineering

   Merck

   Nov 2017 — Present · West Point, PA, US

Education

• University of Delaware

  BChE, Chemical Engineering

  1990 — 1994

Skills

• Technology Transfer
• U.s. Title 21 Cfr Part 11 Regulation
• Verification and Validation (V&V)
• Quality Management
• Quality System
• V&V
• Process Simulation
• Aseptic Processing
• Biotechnology
• Process Engineering
• Capa
• Cleaning Validation
• Gmp
• Gamp
• 21 Cfr Part 11
• Chemical Engineering
• Biopharmaceuticals
• Lean Manufacturing
• Computer System Validation
• Change Control
• R&D
• Validation
• Corrective and Preventive Action (Capa)
• Root Cause Analysis
• Automation
• Pharmaceutical Industry
• Sop
• Fda
• Manufacturing