Biologics Process Engineer - Onsite, Madison

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

Benefits offered by this job

Medical, dental, and vision benefits

Tuition reimbursement

Paid holidays

Competitive PTO

Job summary

Catalent, a global leader in biologics development and manufacturing, is hiring a Process Engineer - Engineering in Madison, WI. This role focuses on optimizing processes, solving technical challenges, and driving strategic projects within a state-of-the-art facility.

You will collaborate with cross-functional teams to support process improvements, troubleshooting, and qualification/validation activities, enabling efficient production and quality outcomes.

Qualifications

• Bachelor’s degree in a scientific/engineering field with 3+ years in facilities operation or automation in a cGMP environment
• Master’s degree with 1+ year in facilities operation or automation in a cGMP environment
• Ability to sit, stand, walk, read, use a computer and lift up to 50 pounds

Responsibilities

• Evaluate existing processes and identify improvements for efficiency and cost savings.
• Lead risk assessments, gap analyses, deviations, change controls, and CAPA.
• Support draft and development of User Requirements Specifications and participate in FAT/SAT and 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 to implementation.
• Track and analyze data for compliance, quality, and day-to-day investigations.

Skills

Cross-functional leadership

Data interpretation

Report writing

Investment in improvements

Problem solving

Root-cause analysis

SOP development

Education

Bachelor’s degree in Industrial, Electrical, Mechanical, Chemical, CS, Civil Engineering or related field

Master’s degree in Industrial, Electrical, Mechanical, Chemical, CS, Civil Engineering or related field

Job description

Catalent, a global leader in biologics development and manufacturing, is hiring a Process Engineer - Engineering in Madison, WI. This role focuses on optimizing processes, solving technical challenges, and driving strategic projects within a state-of-the-art facility.

You will collaborate with cross-functional teams to support process improvements, troubleshooting, and qualification/validation activities, enabling efficient production and quality outcomes.