Process Engineer - Engineering

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

Benefits offered by this job

PTO + holidays

Healthcare from day one

Tuition reimbursement

Job summary

Catalent Madison is hiring a Process Engineer – Engineering to advance biologics development and manufacturing. You will collaborate with cross‑functional teams to optimize processes, troubleshoot, and drive strategic projects in a state‑of‑the‑art facility located in Madison, WI.

The role offers exposure to GPEx technologies and scalable manufacturing platforms. Responsibilities include evaluating processes, supporting risk assessments, deviations, change controls, and qualification testing,

Qualifications

• Bachelor’s degree in engineering with 3+ years in facilities operation or automation in a cGMP biopharma environment
• Master’s degree in engineering with 1+ year in facilities operation or automation in a cGMP environment (biopharma)

Responsibilities

• Evaluate existing processes and identify improvements to enhance efficiency, cost savings, and consistency
• Lead technical support for risk assessments, deviations, change controls, and CAPA activities
• Support drafting User Requirements Specifications and participate in FAT/SAT and qualification/validation testing
• Lead site strategy projects with cross‑department resources and Site Leadership Team visibility
• Oversee technical support of Manufacturing, including change management and troubleshooting
• Support lifecycle management for single‑use GMP manufacturing from design through implementation
• Track and analyze data for compliance, product quality, and continuous improvement
• Perform other duties as assigned

Skills

Cross-functional collaboration

Process optimization

Root cause analysis

Data analysis

Troubleshooting

Documentation

Education

Bachelor's degree in Industrial, Electrical, Mechanical, Chemical, Computer Science, Civil Engineering, or related field

Master's degree in Industrial, Electrical, Mechanical, Chemical, Computer Science, Civil Engineering, or related field

Tools

Change control systems

Job description

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 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.

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

Role Responsibilities

• 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.

Candidate Minimum Requirements

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.

Company & Culture

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.

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life‑saving and life‑enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [e-mail]. This option is reserved for individuals who require accommodation due to a disability.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life‑cycle supply. With time‑tested experience in development sciences, delivery technologies, and multi‑modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life‑enhancing and life‑saving treatments for patients annually.