Principal Process Engineer

3 weeks ago

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

Catalent Biologics is seeking a highly skilled Principal Process Engineer to join our team in Madison, WI. As a key member of our Manufacturing Science and Technology group, you will be responsible for overseeing technical support of Manufacturing, including technology transfer between external clients or Process Development and Manufacturing.

The ideal candidate will have a strong background in biologics process development and manufacturing, with experience in facility fit, process scaling, and technology transfer. You will work closely with a group of engineers, scientists, and other colleagues to drive the facility fit and technical transfer of mammalian biologic processes.

Key Responsibilities
  • Support technology transfer of processes into manufacturing for both internally and externally developed processes.
  • Work cross-functionally with Process Development, Manufacturing, Quality Assurance, Quality Control, Supply Chain, Project Management, Facilities, and other departments to effectively transfer and maintain processes in the facility.
  • Participate in and support strategic alignment across Catalent Biologics sites and the Madison site.
  • Lead and/or support the compilation of process data, including communicating project status, trend identification, and delivering internal or client presentations.
  • Evaluate existing processes and identify process or equipment improvements to advance efficiency, consistency, and competitiveness within the market.
  • Support the building of business case(s) for process improvement projects.
  • Author and review documents, including batch production records, tech transfer reports, bill of materials, process descriptions, project reports, engineering specifications, and summary reports.
  • Act as the lead for technical support of risk assessments, gap analysis, deviations, change controls, and CAPAs, including determination of product or process impact, root-cause analysis, and corrective action identification.
  • Responsible for motivating, coaching, and developing coworkers as a subject matter expert.
Requirements
  • PhD in Engineering, Biotechnology, or related field, with a minimum of 8 years of relevant experience; OR
  • M.S./M.A. in Engineering, Biotechnology, or related field, with a minimum of 12 years of relevant experience; OR
  • B.S./B.A. in Engineering, Biotechnology, or related field, with a minimum of 15 years of relevant experience.
  • Experience with Upstream (mammalian cell culture) processes across cGMP biologics production scales.
  • Experience in facility fit, process scaling, and technology transfer.
  • Experience in writing reports and documentation skills, such as drafting and revising standard operating procedures, batch production records.
  • Direct personnel and organizational group management experience, including mentoring and training staff members cross-functionally.
  • Experience drafting and revising standard operating procedures, batch production records, and reports.
  • Demonstrated working knowledge of Tech Transfer between Development and Manufacturing.
  • Demonstrated understanding of multiple applicable techniques, including purification, buffer preparation, operation, and troubleshooting of stirred vessel bioreactors, incubators, chromatography columns, and processing, and filtration apparatuses.
About Catalent

Catalent is a global leader in the development and manufacture of pharmaceuticals, biologics, and consumer health products. We are committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.

We offer a competitive salary, yearly bonus potential, 152 hours of paid time off annually, 8 paid holidays, medical, dental, and vision benefits effective day one of employment, tuition reimbursement, and a generous 401K match.

Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, please submit your request by sending an email to .

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