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Senior Manufacturing Process Engineer

2 months ago

Athens, United States The Fountain Group Full time

Max Pay: $97.37/Hour

Overview:

  • Provide manufacturing support of current processes and process improvement initiatives as well as providing support to Capital Project initiatives to install new process equipment, production facilities, and/or process utilities.
  • The position is the SME (Subject Matter Expert) for aseptic manufacturing processes.

Responsibilities
  • Analyze new and existing processes. Eliminate sources of contamination, waste, and risk.
  • Optimize efficiency and yield. Identify and drive corrective actions.
  • Lead without authority. Manage projects related to risk reduction and/or process improvement.

Skills:
  • Extensive direct experience in a leading role with the design, implementation, formal qualification, optimization and troubleshooting of aseptic manufacturing processes and equipment.
  • Relevant processes include but are not limited to:
  • Bioreactors
  • Fermenters
  • Concentration/filtration
  • Chromatography
  • Cell propagation
  • CIP/SIP (Clean-In-Place and Sterilize-In-Place)

Education:
  • 8+ years applicable experience engineering or scientific in nature in a GMP environment.
  • Experience with GAMP Automation practices and documents.
  • Basic working knowledge of Allen-Bradley and/or Siemens PLCs (Programmable Logic Controllers).
  • Lean Six Sigma Green Belt (or higher) certification.
  • Certified Maintenance & Reliability Professional (CMRP) certification.
  • 5+ years' experience leading projects.
  • Experience using, developing, and leading recognized process optimization tools in a manufacturing facility.