Process Engineer - Engineering
Listed on 2026-08-24
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Engineering
Quality Engineering, Process Engineer
About Site
Catalent’s Madison, Wisconsin site is a state‑of‑the‑art biologics development and manufacturing facility supporting customers from research through early‑and mid‑stage clinical production. Located at 726 Heartland Trail in Madison, the approximately 102,700‑square‑foot GMP facility specializes in mammalian cell line engineering, drug substance biomanufacturing, and biopharmaceutical development, utilizing flexible single‑use systems to enable rapid scale‑up and customization. The site is home to Catalent’s proprietary GPEx® and GPEx® Lightning technologies, which are used to generate high‑yielding mammalian cell lines for biologic therapies, and supports production scales ranging from 50 to 4,000 liters for clinical manufacturing.
Following a $45 million expansion announced in 2025, the Madison site has significantly increased capacity, added new equipment, and created approximately 200 highly skilled biohealth jobs, further strengthening its role within Catalent’s global biologics network and Wisconsin’s growing life sciences ecosystem.
We have an opportunity for a Process Engineer - Engineering to join our team and contribute to advancing biologics development and manufacturing. This role offers the chance to work in a dynamic environment focused on innovation and continuous improvement. You will collaborate with cross-functional teams to support process optimization, technical troubleshooting, and strategic projects. This is an exciting opportunity to make an impact on life‑changing therapies while growing your career in a state‑of‑the‑art facility.
Shift: Monday
-Friday, 8:00 AM-4:30 PM or 8:30 AM-5:00 PM with a 30-minute unpaid lunch
Location:
Madison, WI
100% Onsite
The Role- 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 and corrective action identification.
- 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, troubleshooting, and oversight of site strategy projects.
- 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 day‑to‑day investigations and troubleshooting.
- Perform other duties as assigned.
Minimum Requirements
- Bachelor’s degree in Industrial, Electrical, Mechanical, Chemical, Computer Science, Civil Engineering, or related scientific/engineering field with 3+ years of facilities operation or automation engineering experience in a cGMP environment (preferably biopharmaceutical) OR
- Master’s degree in Industrial, Electrical, Mechanical, Chemical, Computer Science, Civil Engineering, or related scientific/engineering field with 1+ year of facilities operation or automation engineering experience in a cGMP environment (preferably biopharmaceutical).
- Requires frequent sitting, standing, walking, reading documents, computer use, reaching, communication, and writing, with occasional bending, kneeling, crouching, carrying, and lifting up to 50 pounds.
- Previous experience leading cross-department facility and/or site improvement projects is a plus.
- Ability to create and deliver complex reports and presentations.
- Ability to interpret data, analyze trends, and provide insights into potential issues and solutions.
- Ability to complete investigation, deviation, and change control forms independently.
- Ability to introduce new technology and drive process improvements, collaborating with other groups to develop, qualify, and transfer methods.
- Experience in writing, editing, and reviewing…
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