Senior Downstream Biologics Process Engineer (MS&T)

Catalent Pharma Solutions; United States; On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Paid holidays & PTO

Medical/dental/vision benefits

Tuition reimbursement

Equal opportunity employer

Job summary

Catalent's Madison, Wisconsin site seeks a Senior Process Engineer - Manufacturing Sciences & Technology, Downstream, to drive downstream biologics processes and technology transfer into GMP manufacturing. You’ll collaborate across Process Development, Manufacturing, QA/QC, and Facilities to enable robust, scalable operations and ensure regulatory readiness.

The role emphasizes developing and guiding process transfer strategies, authoring technical documents, supervising staff, and leading

Qualifications

• Minimum of Associate’s degree in STEM with 12+ years of related experience, or Bachelor’s in STEM with 6+ years, or Master’s with 4+ years, or Doctorate in STEM without formal industry experience.
• Experience in mRNA product development, mRNA manufacturing, protein therapeutics manufacturing, and late stage/commercial manufacturing.
• Experience authoring, revising, and reviewing technical documentation, including reports, standard operating procedures, and batch production records, supported by statistical data analysis.
• Proven leadership experience managing and mentoring staff, including cross‑functional training and personnel development.
• Hands‑on experience investigating, resolving, and closing deviations, out‑of‑specification events, change controls, and CAPAs in a cGMP‑regulated environment.
• Technical expertise in downstream biologics manufacturing processes such as depth filtration, chromatography, tangential flow filtration, and viral filtration, including facility fit, process scaling, and technology transfer.
• Operational engineering experience supporting late‑phase, PPQ, and commercial programs, including design, qualification, operation, and troubleshooting of single‑use systems and manufacturing equipment for biologics and molecular therapeutics.

Responsibilities

• Oversee technical support of Manufacturing, including technology transfer between external clients or Process Development and Manufacturing.
• Collaborate with engineers, scientists, and colleagues to drive facility fit and technical transfer of mammalian biologic processes.
• Evaluate, align, and recommend equipment and process improvements.
• Support technology transfer of processes into manufacturing for internal and external projects.
• Develop and execute technical work plans and schedules independently using customer milestones and site performance standards.
• Author and approve technical documents such as protocols, technology transfer reports, operating procedures, and batch production records.
• Review technical documents for accuracy, thoroughness, and regulatory compliance.
• Train, coach, and mentor others on technical topics.
• Participate in client meetings, providing technical support and leading projects as a technical lead across multiple disciplines.
• Identify and recommend business opportunities on a project-specific basis.
• Work cross-functionally with Process Development, Manufacturing, QA, QC, Supply Chain, Project Management, and Facilities to ensure effective process transfer and maintenance.
• Support strategic alignment across Catalent Biologics sites, including the Madison site.
• Collaborate with Manufacturing to author batch documentation and provide technical and strategic oversight for GMP manufacturing.
• Compile process data, communicate project status, identify trends, and deliver internal or client presentations.
• Evaluate existing processes and identify process or equipment improvements to enhance efficiency and competitiveness.
• Support the development of business cases for process improvement projects.
• Author and review documents including batch production records, tech transfer reports, bill of materials, process descriptions, project reports, engineering specifications, and summary reports.
• Lead or support risk assessments, gap analyses, deviations, change controls, and CAPAs, including root-cause analysis and corrective action identification.
• Other duties as assigned.

Skills

Technology transfer

Process engineering

Downstream bioprocessing

Team leadership

cGMP compliance

Education

Associate degree in STEM

Bachelor’s degree in STEM

Master’s degree in STEM

PhD in STEM

Tools

Single-use systems

Chromatography

Tangential flow filtration

Viral filtration

Job description

Catalent's Madison, Wisconsin site seeks a Senior Process Engineer - Manufacturing Sciences & Technology, Downstream, to drive downstream biologics processes and technology transfer into GMP manufacturing. You’ll collaborate across Process Development, Manufacturing, QA/QC, and Facilities to enable robust, scalable operations and ensure regulatory readiness.

The role emphasizes developing and guiding process transfer strategies, authoring technical documents, supervising staff, and leading