Downstream Tech Transfer Engineer – Biologics GMP

Catalent; Madison (WI); On-site; USD 95,000 - 135,000; Full time

Benefits offered by this job

Health insurance

401K match

Paid time off

Tuition reimbursement

Job summary

Catalent's Madison, WI facility is seeking a Process Engineer for MS&T Downstream Technology Transfer to support transfer and execution of biologics processes. You will collaborate across e.g., Process Development and Manufacturing to ensure scalable, compliant operations.

The ideal candidate will have 6+ years in biotech process roles, strong documentation skills, and hands-on experience with deviations, CAPAs, and cGMP manufacturing. This role is on-site in Madison, WI.

Qualifications

• Associate degree in STEM with 6+ years of related experience.
• Preferred Bachelor’s and/or Master’s with 3+ years in bioprocessing.
• Experience authoring SOPs, reports, and batch records with data analysis.
• Proven leadership, mentoring, and cross-functional collaboration.
• Hands-on experience with deviations, CAPAs, and cGMP environments.

Responsibilities

• Provide tech transfer support for downstream biologics processes.
• Lead technology transfer and equipment alignment across sites.
• Draft and review technical documentation and reports.
• Support GMP manufacturing with batch documentation and risk assessments.
• Coach junior staff and collaborate with multiple departments.

Skills

Process engineering

Technology transfer

Regulatory compliance

Data analysis

Leadership

SOPs writing

Education

Associate degree in STEM

Bachelor's degree (preferred)

Master's degree (preferred)

Tools

Filtration systems

Chromatography

TFF (Tangential Flow Filtration)

IVT processes

Job description

Catalent's Madison, WI facility is seeking a Process Engineer for MS&T Downstream Technology Transfer to support transfer and execution of biologics processes. You will collaborate across e.g., Process Development and Manufacturing to ensure scalable, compliant operations.

The ideal candidate will have 6+ years in biotech process roles, strong documentation skills, and hands-on experience with deviations, CAPAs, and cGMP manufacturing. This role is on-site in Madison, WI.