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Process Engineer, Active Ingredient
3 months ago
Duties:
This role has the responsibility of providing 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.
Tasks & 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:
Preferred requirements:
- 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:
- Eight-plus (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.
- Five-plus (5+) years’ experience leading projects.
- Experience using, developing, and leading recognized process optimization tools in a manufacturing facility.
Pay Rate Range: $60-100/hr. *Salary will be commensurate with experience
