Process Engineer - Engineering

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

Process Engineer - Engineering

About Site

Catalent’s Madison, Wisconsin site is a state‑of‑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‑…

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. 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. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

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.