Process Engineer

Curium

Noblesville, IN, United States
On-site
Process improvement and reliability
Troubleshooting manufacturing equipment
Root cause analysis methodologies
The Process Engineer will be a key contributor in a dynamic manufacturing organization supporting fast-paced manufacturing of radiopharmaceutical therapeutic sterile drug products

Job Summary

  • The Process Engineer will be a key contributor in a dynamic manufacturing organization supporting fast-paced manufacturing of radiopharmaceutical therapeutic sterile drug products.
  • The role will develop solutions and implement new technology to improve the reliability and quality of the manufacturing process through writing and implementing change controls and corrective and preventative actions.
  • Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).

Matching Summary

The Process Engineer will be a key contributor in a dynamic manufacturing organization supporting fast-paced manufacturing of radiopharmaceutical therapeutic sterile drug products.

Skills & Requirements

Must-have

  • Process improvement and reliability
  • Troubleshooting manufacturing equipment
  • Root cause analysis methodologies
  • cGMP compliance and quality systems
  • FDA regulated GMP facility experience
  • Sterile drug product manufacturing

Nice-to-have

  • Agile approach and willingness to learn
  • Aseptic technique knowledge
  • Radioactive isotopes and radiation safety
  • Lean Manufacturing applications
  • Operational Excellence initiatives

Key Requirements

  • Bachelor’s Degree in Engineering or related field
  • 3 years or more of experience
  • Experience leading formal Root Cause Analysis
  • Knowledge of cGMP's, validation, quality systems

Work Rights

Not specified

Tailored Resume

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