Onsite Biologics Process Engineer

Catalent Pharma Solutions; Madison (WI); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

PTO + holidays

Healthcare from day one

Tuition reimbursement

Job summary

Catalent Madison is hiring a Process Engineer – Engineering to advance biologics development and manufacturing. You will collaborate with cross‑functional teams to optimize processes, troubleshoot, and drive strategic projects in a state‑of‑the‑art facility located in Madison, WI.

The role offers exposure to GPEx technologies and scalable manufacturing platforms. Responsibilities include evaluating processes, supporting risk assessments, deviations, change controls, and qualification testing,

Qualifications

• Bachelor’s degree in engineering with 3+ years in facilities operation or automation in a cGMP biopharma environment
• Master’s degree in engineering with 1+ year in facilities operation or automation in a cGMP environment (biopharma)

Responsibilities

• Evaluate existing processes and identify improvements to enhance efficiency, cost savings, and consistency
• Lead technical support for risk assessments, deviations, change controls, and CAPA activities
• Support drafting User Requirements Specifications and participate in FAT/SAT and qualification/validation testing
• Lead site strategy projects with cross‑department resources and Site Leadership Team visibility
• Oversee technical support of Manufacturing, including change management and troubleshooting
• Support lifecycle management for single‑use GMP manufacturing from design through implementation
• Track and analyze data for compliance, product quality, and continuous improvement
• Perform other duties as assigned

Skills

Cross-functional collaboration

Process optimization

Root cause analysis

Data analysis

Troubleshooting

Documentation

Education

Bachelor's degree in Industrial, Electrical, Mechanical, Chemical, Computer Science, Civil Engineering, or related field

Master's degree in Industrial, Electrical, Mechanical, Chemical, Computer Science, Civil Engineering, or related field

Tools

Change control systems

Job description

Catalent Madison is hiring a Process Engineer – Engineering to advance biologics development and manufacturing. You will collaborate with cross‑functional teams to optimize processes, troubleshoot, and drive strategic projects in a state‑of‑the‑art facility located in Madison, WI.

The role offers exposure to GPEx technologies and scalable manufacturing platforms. Responsibilities include evaluating processes, supporting risk assessments, deviations, change controls, and qualification testing,