Process Engineer - Engineering

Position Summary

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.

The Candidate

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.

Preferred Skills & Background

• 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 Standard Operating Procedures.

Why You Should Join Catalent

• 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.