Biologics Process Engineer (Onsite) — Madison

Catalent Pharma Solutions; United States; On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Tuition reimbursement

Health benefits from day one

Job summary

Catalent’s Madison, Wisconsin site is seeking a Process Engineer - Engineering to advance biologics development and manufacturing. You will collaborate with cross‑functional teams to optimize processes, troubleshoot technical issues, and drive strategic projects in a dynamic, on‑site work environment.

The role involves risk assessments, change controls, and validation activities, with shift and onsite location in Madison, WI.

Qualifications

• Requires a bachelor’s degree in an engineering field and 3+ years in facilities operation or automation engineering in a cGMP environment (biopharma preferred).
• Or a master’s degree with 1+ year of relevant experience in a cGMP environment (biopharma preferred).
• Frequent sitting, standing, walking, reading, computer use, with occasional lifting up to 50 lbs.

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 and preventive actions, including root‑cause analysis.
• Support drafting and development of User Required Specifications and participate in Factory Acceptance Testing, Site Acceptance Testing, and Qualification/Validation testing for new and existing technologies.
• Lead site strategy projects with cross‑department resources and Site Leadership Team visibility through implementation.
• Oversee technical support of Manufacturing, including change management and troubleshooting.
• Support consumable and raw material lifecycle management for single‑use GMP manufacturing from design through implementation.
• Track, trend, and analyze data for compliance, product quality, continuous improvement, and investigations.

Skills

Problem solving

Data analysis

Cross‑functional collaboration

Technical troubleshooting

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

Tools

cGMP knowledge

Job description

Catalent’s Madison, Wisconsin site is seeking a Process Engineer - Engineering to advance biologics development and manufacturing. You will collaborate with cross‑functional teams to optimize processes, troubleshoot technical issues, and drive strategic projects in a dynamic, on‑site work environment.

The role involves risk assessments, change controls, and validation activities, with shift and onsite location in Madison, WI.