Biologics Upstream Process Engineer – Tech Transfer

Catalent Pharma Solutions; Kentucky; On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

Paid time off + 8 holidays

Tuition reimbursement

Housing support or relocation details

Job summary

Catalent is seeking a Process Engineer in Madison, WI for Manufacturing Sciences & Technology, Upstream Technology Transfer. You will support tech transfer and process readiness for biologics, working with cross-functional teams in a GMP setting.

The role involves drafting and reviewing technical docs, leading risk assessments and CAPAs, optimizing upstream processes, and mentoring junior staff. Experience with mammalian cell culture or in vitro transcription and cGMP environments is valued.

Qualifications

• Associate's degree in STEM with 6+ years of related experience, or Bachelor's/Master's with 3+ years.
• Experience in mRNA product development, mRNA manufacturing, protein therapeutics manufacturing, and late-stage/commercial manufacturing.
• Experience authoring, revising, and reviewing technical documentation with statistical data analysis.
• Proven leadership experience mentoring staff and cross-functional training.
• Experience in a cGMP-regulated environment handling deviations, CAPAs, and risk assessments.

Responsibilities

• Provide technical support to Manufacturing, leading facility fit, equipment alignment, and technology transfer of biologic processes.
• Draft, author, and review technical documentation including development reports and batch records.
• Lead or support risk assessments, deviations, change controls, and CAPAs with root-cause analysis.
• Collaborate cross-functionally with Process Development, Manufacturing, QA, QC, Supply Chain, and Facilities to enable process transfer.

Skills

Cross-functional collaboration

Technical documentation

Data analysis

Leadership & mentoring

Regulatory compliance

Education

Associate’s degree in STEM

Bachelor’s or Master’s degree in STEM

Job description

Catalent is seeking a Process Engineer in Madison, WI for Manufacturing Sciences & Technology, Upstream Technology Transfer. You will support tech transfer and process readiness for biologics, working with cross-functional teams in a GMP setting.

The role involves drafting and reviewing technical docs, leading risk assessments and CAPAs, optimizing upstream processes, and mentoring junior staff. Experience with mammalian cell culture or in vitro transcription and cGMP environments is valued.