Senior Upstream Process Engineer, Biologics MST

Catalent Pharma Solutions; Madison (WI); On-site; USD 150,000 - 210,000; Full time

Job summary

Catalent Pharma Solutions in Madison, WI is seeking a Principal Process Engineer to provide on-call and on-the-floor technical support to manufacturing. You will draft and review documents, compile process data, and contribute to investigations and change controls.

This client-facing role requires collaboration with clients and internal teams to move projects forward, with a Monday–Friday schedule and 100% onsite at the Madison site.

Qualifications

• Strong documentation and record-keeping skills.
• Experience drafting and revising SOPs and batch records.
• Proficiency with data analysis and statistical techniques.
• Experience leading cross-functional teams on complex biotech projects.
• Experience with technology transfer in biopharma.

Responsibilities

• Develop and execute technical work plans and schedules.
• Author and review protocols, tech transfer reports, and batch records.
• Provide client-facing technical support and lead cross-disciplinary projects.
• Collaborate with manufacturing and engineering to transfer processes.
• Lead risk assessments, deviations, CAPAs, and change controls.

Skills

Mentoring staff

Cross-functional collaboration

Technical leadership

Documentation skills

Statistical data analysis

Education

Bachelor’s degree in STEM

Master’s degree in STEM

Doctorate in STEM

Tools

Single-use systems

GMP manufacturing

Process equipment troubleshooting

Job description

Catalent Pharma Solutions in Madison, WI is seeking a Principal Process Engineer to provide on-call and on-the-floor technical support to manufacturing. You will draft and review documents, compile process data, and contribute to investigations and change controls.

This client-facing role requires collaboration with clients and internal teams to move projects forward, with a Monday–Friday schedule and 100% onsite at the Madison site.