Process Engineer

2 weeks ago


Bloomington, United States Catalent Inc Full time
Job Summary

Catalent is seeking a Process Engineer to oversee and optimize manufacturing processes related to the production of sterile biologic drug products. The successful candidate will design, implement, and improve manufacturing processes to enhance product quality, yield, and efficiency.

Key Responsibilities
  • Optimize manufacturing processes to produce sterile products, including upstream and downstream processes.
  • Design and implement process improvements to enhance product quality, yield, and efficiency.
  • Perform process risk assessments and lead investigations into process deviations.
  • Collaborate with cross-functional teams to support product commercial manufacturing activities.
  • Develop process documentation, including standard operating procedures (SOPs), protocols, and other GMP documents.
  • Provide technical support, oversight, and training to manufacturing personnel.
Requirements
  • Bachelor's degree in Chemical, Mechanical, or Electrical Engineering or an appropriate scientific discipline.
  • 8 years of engineering experience in lieu of the degree.
  • PE/Registered Engineer in training, preferred.
  • OSHA 10 or equivalent, a plus.
  • 2+ years of Project Engineering related experience.
  • Strong understanding of cGMP regulations, FDA guidelines, and industry standards related to sterile manufacturing.
  • Excellent problem-solving skills and the ability to troubleshoot complex manufacturing issues.
  • Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
  • Detail-oriented approach with a commitment to quality and compliance.
About Catalent

Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide.

Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us.

Join us in making a difference.


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