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Senior Process Engineer for Active Ingredients

2 months ago

Athens, Georgia, United States Planet Pharma Full time

Position Overview:

The Senior Process Engineer for Active Ingredients is tasked with delivering manufacturing support for ongoing processes and spearheading initiatives aimed at process enhancement. This role also encompasses providing assistance for Capital Project initiatives that involve the installation of new process equipment, production facilities, and process utilities. The individual will serve as the Subject Matter Expert (SME) in aseptic manufacturing processes.

Key Responsibilities:

  • Evaluate both new and existing processes to identify and eliminate sources of contamination, waste, and risk.
  • Enhance efficiency and yield through systematic analysis.
  • Recognize and implement corrective actions proactively.
  • Lead initiatives and projects effectively, even without direct authority.
  • Oversee projects focused on risk mitigation and process optimization.

Required Skills and Qualifications:

Preferred Qualifications:

  • Significant hands-on experience in a leadership capacity involving the design, implementation, formal qualification, optimization, and troubleshooting of aseptic manufacturing processes and associated equipment.
  • Familiarity with relevant processes, including but not limited to:
    • Bioreactors
    • Fermenters
    • Concentration and filtration techniques
    • Chromatography
    • Cell propagation methods
    • CIP/SIP (Clean-In-Place and Sterilize-In-Place) protocols

Educational Background:

  • A minimum of eight (8) years of relevant engineering or scientific experience within a GMP environment.
  • Experience with GAMP Automation practices and documentation.
  • Basic proficiency in Allen-Bradley and/or Siemens PLCs (Programmable Logic Controllers).
  • Lean Six Sigma Green Belt certification or higher.
  • Certified Maintenance & Reliability Professional (CMRP) certification.
  • At least five (5) years of experience leading projects.
  • Proficient in utilizing, developing, and leading recognized process optimization tools within a manufacturing setting.

Compensation: $60-100/hr. *Salary will be determined based on experience.