Process Engineer

5 days ago


Madison WI USA, United States Catalent Inc Full time
About the Role

Catalent is seeking a highly skilled Process Engineer to join our Biologics Manufacturing team. As a Process Engineer, you will be responsible for supporting the development and implementation of biologics manufacturing processes, ensuring compliance with regulatory requirements and company standards.

Key Responsibilities
  • Support the development and implementation of biologics manufacturing processes, including process design, scale-up, and validation.
  • Collaborate with cross-functional teams, including Process Development, Manufacturing, Quality Assurance, and Quality Control, to ensure seamless process transfer and maintenance.
  • Author and review batch production records, tech transfer reports, and other documentation to ensure accuracy and compliance.
  • Provide technical and strategic oversight associated with GMP manufacturing, including process optimization and troubleshooting.
  • Lead and/or support the compilation of process data, including communicating project status, trend identification, and delivering internal or client presentations.
Requirements
  • MS in engineering, biotechnology, or a related field with at least 0-2 years of biopharmaceutical process development and/or manufacturing experience.
  • BS/BA in engineering, biotechnology, or a related field with 3-6 years of biopharmaceutical process development and/or manufacturing experience.
  • Associate degree in a related field with at least 6-9 years of biopharmaceutical process development and manufacturing experience.
  • Experience with Upstream (mammalian cell culture), Downstream (chromatography, tangential flow filtration, etc.) and/or molecular therapeutics (mRNA or new modality) processes across cGMP production scales.
  • Experience with design, onboarding, qualification, and troubleshooting biologics/molecular therapeutics single-use consumables and/or manufacturing equipment.
About Catalent

Catalent is a global leader in the development and manufacture of pharmaceuticals, biologics, and consumer health products. We are committed to helping our customers bring innovative products to market quickly and efficiently, while ensuring the highest quality and compliance standards.


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