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Process Engineer - Manufacturing Sciences & Technology (MS&T), Downstream Technology Transfer

Catalent · Madison, WI

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Role summary

Catalent seeks a Process Engineer for downstream technology transfer in a GMP-regulated biologics manufacturing facility in Madison, Wisconsin. The role involves supporting process transfer, technology implementation, and GMP operations across diverse biologic modalities while collaborating cross-functionally with development and manufacturing teams.

What they're looking for

  • Associate's degree in STEM with 6+ years related experience; Bachelor's or Master's preferred with 3+ years
  • Experience with mRNA, protein therapeutics, or commercial-scale manufacturing
  • Demonstrated expertise authoring and reviewing technical documentation, SOPs, and batch records
  • Hands-on experience investigating deviations, OOS events, and CAPAs in cGMP environments
  • Subject matter expertise in downstream processes: filtration, chromatography, TFF, viral filtration
  • Operational engineering experience with single-use systems, PPQ, and commercial program scale-up
  • Proven leadership and mentoring experience in cross-functional settings

What you'll be doing

  • Provide technical support for facility fit, equipment alignment, and biologic process technology transfer from development to manufacturing
  • Execute technical work plans, perform engineering calculations, and generate data supporting development and GMP programs
  • Author and review technical documentation including reports, batch records, specifications, and compliance materials
  • Support GMP manufacturing through technical oversight, batch documentation, and close collaboration with manufacturing teams
  • Lead or support risk assessments, gap analyses, deviations, change controls, and CAPA investigations

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Date posted1 day ago
Last source check1 day ago
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