MS&T Process Engineer - Biologics Tech Transfer (On-Site)

Catalent

Madison (WI)

On-site

USD 95,000 - 130,000

Full time

2 days ago
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Benefits offered by this job

Diverse, inclusive culture
152 hours PTO + 8 paid holidays
401K match
Medical, dental and vision benefits
Tuition Reimbursement

Job summary

Catalent, Inc. in Madison, WI is seeking a Process Engineer for MS&T to support technology transfer and scale-up of biologics processes.

You will work upstream and downstream transfer, draft technical reports, and collaborate with cross-functional teams to enable compliant, robust manufacturing. The role requires a STEM degree with 6+ years of related experience, strong data analysis, and hands-on experience with deviations, CAPAs, and cGMP environments.

Qualifications

  • Associate degree in STEM with 6+ years of related experience (Bachelor/Master preferred).
  • Experience authoring/revising technical documentation with data analysis support.
  • Proven leadership, mentoring, and cross‑functional training experience.
  • Experience resolving deviations, OOS events, change controls, and CAPAs in a cGMP setting.
  • Technical expertise in upstream/downstream biologics manufacturing and tech transfer.

Responsibilities

  • Provide technical oversight to Manufacturing and lead technology transfer of biologic processes.
  • Draft, review, and support development and transfer documentation and reports.
  • Lead risk assessments, gap analyses, deviations, changes, and CAPAs with root cause analysis.
  • Collaborate cross‑functionally to enable process transfer and sustainment.
  • Mentor junior staff and participate in client meetings as a SME.

Skills

Leadership
Data analysis
Documentation
Mentoring
Problem solving

Education

Associate’s degree in STEM
Bachelor’s/Master’s in STEM preferred

Job description

Catalent, Inc. in Madison, WI is seeking a Process Engineer for MS&T to support technology transfer and scale-up of biologics processes.

You will work upstream and downstream transfer, draft technical reports, and collaborate with cross-functional teams to enable compliant, robust manufacturing. The role requires a STEM degree with 6+ years of related experience, strong data analysis, and hands-on experience with deviations, CAPAs, and cGMP environments.

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