Process Engineer - Engineering

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 generate high-yielding mammalian cell lines for biologic therapies, and supports production scales ranging from 50 to 4,000 liters for clinical manufacturing.

About the Role

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.

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 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.

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.

Preferred Skills

• Previous experience leading cross-department facility and/or site improvement projects.
• 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 Standard Operating Procedures.

Schedule

Monday - Friday, 8:00 AM - 4:30 PM or 8:30 AM - 5:00 PM with a 30-minute unpaid lunch. 100% onsite in Madison, WI.

Benefits

• Defined career path with annual performance reviews and feedback.
• Diverse and inclusive culture.
• Opportunities for career growth within an organization dedicated to improving lives.
• Competitive paid time off plus 8 paid holidays.
• Community engagement and green initiatives.
• Medical, dental, and vision benefits effective from day one.
• Tuition reimbursement program.