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Senior Process Engineer in Manufacturing

2 months ago

Athens, Georgia, United States Compunnel Inc. Full time

Job Title: Senior Process Engineer

Contract Duration: 6 Months (Potential for Extension)

Location: Remote

Overview:

This position involves providing expert manufacturing support for existing operations and driving process enhancement initiatives. The role also encompasses assisting with capital project efforts aimed at the installation of new manufacturing equipment, production facilities, and related utilities. The selected candidate will serve as the Subject Matter Expert (SME) for sterile manufacturing methodologies.

Key Responsibilities:

  • Evaluate both new and established processes to eliminate contamination, waste, and risks.
  • Enhance operational efficiency and product yield.
  • Identify and implement corrective measures while leading initiatives without direct authority.
  • Oversee projects focused on risk mitigation and process optimization.

Preferred Qualifications:

The ideal candidate will possess extensive experience in a leadership capacity concerning the design, execution, formal validation, optimization, and troubleshooting of sterile manufacturing processes and associated equipment.

Relevant processes include, but are not limited to:

  • Bioreactors
  • Fermenters
  • Concentration and filtration
  • Chromatography
  • Cell propagation
  • CIP/SIP (Clean-In-Place and Sterilize-In-Place)

Educational Background:

A minimum of eight (8) years of relevant engineering or scientific experience within a GMP environment is required.

Familiarity with GAMP Automation practices and documentation is essential.

Basic knowledge of Allen-Bradley and/or Siemens PLCs (Programmable Logic Controllers) is advantageous.

Certifications such as Lean Six Sigma Green Belt (or higher) and Certified Maintenance & Reliability Professional (CMRP) are preferred.

Experience leading projects for over five (5) years is essential.

Proficiency in utilizing, developing, and leading recognized process optimization methodologies in a manufacturing context is expected.