Biologics Upstream Process Engineer – Tech Transfer

Ourlivesmadison; Madison, Northern (WI, KY); Hybrid; USD 95,000 - 150,000; Full time

Benefits offered by this job

Competitive PTO

Medical, dental, vision benefits

Tuition reimbursement

Job summary

Catalent is seeking a Process Engineer – Manufacturing Sciences & Technology, Upstream Technology Transfer, to join our Madison, WI team. This onsite role supports transfer and readiness of biologics manufacturing, working with cross-functional groups to ensure successful execution.

You will contribute to technology transfer, process optimization, and documentation in a GMP environment, with opportunities to mentor junior staff and collaborate across Catalent Biologics locations.

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, including reports, SOPs, and batch records, supported by data analysis
• Proven leadership experience managing and mentoring staff across cross-functional teams
• Hands-on experience investigating, resolving deviations, out-of-spec events, change controls, and CAPAs in a cGMP environment
• Technical subject matter expertise in upstream/downstream biologics processes, including facility fit, process scaling, and tech transfer across cGMP production scales
• Operational engineering experience supporting late-phase, process performance qualification, and commercial programs, including single-use systems and manufacturing equipment

Responsibilities

• Provide technical support to manufacturing, leading facility fit, equipment alignment, and technology transfer of biologic processes
• Evaluate and recommend process improvements while supporting technology transfer
• Execute technical work plans, data generation, and entry in collaboration with supervisors
• Draft, review, and author technical documentation and reports
• Lead technical reviews of lab and engineering documentation for accuracy and regulatory compliance
• Support GMP manufacturing through oversight, batch documentation, and collaboration with Manufacturing teams
• Lead or contribute to risk assessments, deviations, CAPAs, and root cause analyses
• Identify process or equipment improvements to enhance efficiency and competitiveness
• Communicate status and trends to stakeholders and clients
• Collaborate cross-functionally to enable effective transfer and sustainment across sites

Skills

mRNA development

Biologics manufacturing

Documentation expertise

Leadership

CAPA investigations

Technology transfer

Single-use systems

Education

Associate’s degree in STEM

Bachelor’s or Master’s in STEM

Job description

Catalent is seeking a Process Engineer – Manufacturing Sciences & Technology, Upstream Technology Transfer, to join our Madison, WI team. This onsite role supports transfer and readiness of biologics manufacturing, working with cross-functional groups to ensure successful execution.

You will contribute to technology transfer, process optimization, and documentation in a GMP environment, with opportunities to mentor junior staff and collaborate across Catalent Biologics locations.