Biologics Process Engineer – Onsite, Madison

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

Benefits offered by this job

Benefits from day one

Tuition reimbursement

PTO & holidays

Job summary

Catalent’s Madison, Wisconsin site is seeking a Process Engineer - Engineering to advance biologics development and manufacturing. You will support process optimization, troubleshooting, and cross‑functional projects in a state‑of‑the‑art facility.

This 100% onsite role requires collaboration with manufacturing, quality, and engineering teams; candidates should have a degree in engineering with 3+ years of cGMP experience or a master’s with 1+ year. Competitive benefits included.

Qualifications

• Bachelor’s degree in engineering/science with 3+ years of facilities operation or automation experience in a cGMP environment.
• Master’s degree with 1+ year of facilities operation or automation experience in a cGMP environment.
• Frequent movement and lifting up to 50 lbs as part of the role.

Responsibilities

• Evaluate existing processes and identify improvements to enhance efficiency, cost savings, time savings, consistency, and competitiveness.
• Lead technical support for risk assessments, gap analysis, deviations, change controls, and corrective actions, including root-cause analysis.
• Support drafting and development of User Required Specifications and participate in testing activities (FAT/SAT/Qualification/Validation).
• Lead site strategy projects with cross-department resources and Site Leadership Team visibility.
• Oversee technical support of Manufacturing and change management activities.
• Support lifecycle management for single‑use GMP manufacturing from design through implementation.
• Track, trend, and analyze data for compliance, product quality, and continuous improvement.

Skills

Cross‑department projects

Report writing

Data analysis

Investigation & CAPA forms

Process improvements

SOP writing

Education

Bachelor’s degree in Industrial, Electrical, Mechanical, Chemical, Computer Science, Civil Engineering, or related scientific/engineering field

Master’s degree in Industrial, Electrical, Mechanical, Chemical, Computer Science, Civil Engineering, or related scientific/engineering field

Job description

Catalent’s Madison, Wisconsin site is seeking a Process Engineer - Engineering to advance biologics development and manufacturing. You will support process optimization, troubleshooting, and cross‑functional projects in a state‑of‑the‑art facility.

This 100% onsite role requires collaboration with manufacturing, quality, and engineering teams; candidates should have a degree in engineering with 3+ years of cGMP experience or a master’s with 1+ year. Competitive benefits included.