Process Engineer - Engineering

Catalent Pharma Solutions; Madison (WI); Presencial; USD 85.000 - 110.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, dental, and vision benefits

Tuition reimbursement

Paid holidays

Competitive PTO

Descripción de la vacante

Catalent, a global leader in biologics development and manufacturing, is hiring a Process Engineer - Engineering in Madison, WI. This role focuses on optimizing processes, solving technical challenges, and driving strategic projects within a state-of-the-art facility.

You will collaborate with cross-functional teams to support process improvements, troubleshooting, and qualification/validation activities, enabling efficient production and quality outcomes.

Formación

• Bachelor’s degree in a scientific/engineering field with 3+ years in facilities operation or automation in a cGMP environment
• Master’s degree with 1+ year in facilities operation or automation in a cGMP environment
• Ability to sit, stand, walk, read, use a computer and lift up to 50 pounds

Responsabilidades

• Evaluate existing processes and identify improvements for efficiency and cost savings.
• Lead risk assessments, gap analyses, deviations, change controls, and CAPA.
• Support draft and development of User Requirements Specifications and participate in FAT/SAT and 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 to implementation.
• Track and analyze data for compliance, quality, and day-to-day investigations.

Conocimientos

Cross-functional leadership

Data interpretation

Report writing

Investment in improvements

Problem solving

Root-cause analysis

SOP development

Educación

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

Descripción del empleo

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

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.

Visit Catalent Careers to explore career opportunities.

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Massachusetts Lie Detector Test Notice

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.

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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.