Principal Process Engineer - Manufacturing Sciences & Technology, Upstream

Catalent Pharma Solutions; Madison (WI); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Career growth

Inclusive culture

Benefits from day one

Tuition reimbursement

Job summary

Catalent’s Madison, WI site is a state-of-the-art biologics development and manufacturing facility supporting customers from research through early-and mid-stage clinical production. The Principal Process Engineer - Manufacturing Sciences & Technology provides on-call and on-the-floor technical support to manufacturing.

The role involves drafting and reviewing documentation, compiling process data, and guiding investigations and change controls.

Qualifications

• Experience in documenting and revising technical documents and batch production records.
• Experience using statistical techniques for data analysis and reporting.
• Direct personnel management including mentoring and training staff cross-functionally.
• Experience investigating deviations, implementing CAPAs and closing investigations.

Responsibilities

• Develop technical work plans and schedules for projects.
• Author and approve protocols, tech transfer reports, and batch records.
• Collaborate with cross-functional teams to transfer processes and maintain GMP standards.
• Provide technical oversight for risk assessments, deviations, and CAPAs.
• Lead client meetings and support multiple customers across sites.

Skills

Process engineering leadership

Documentation

Statistical data analysis

Team mentoring

Technology transfer

GMP knowledge

Education

Bachelor's degree in STEM

Master's degree in STEM

Doctorate in STEM

Tools

Single-use systems

Process equipment troubleshooting

Tech transfer

Job description

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 Principal Process Engineer - Manufacturing Sciences & Technology to join our team. This role provides on-call and on-the-floor technical support to manufacturing. The position involves drafting and reviewing documentation, compiling and assessing process data, and providing technical input for investigations and change controls. It is client-facing and requires strong collaboration with clients and internal teams to move projects forward.

Shift: Monday - Friday, core hours 8am-5pm
Location: Madison, WI
100% Onsite

The Role

• Develop and execute technical work plans and schedules independently, ensuring projects stay within scope and meet performance standards.
• Author and approve technical documents such as protocols, technology transfer reports, operating procedures, and batch production records.
• Review technical documents for accuracy, completeness, and regulatory compliance.
• Train, coach, and mentor others on technical and business topics. Motivate, coach, and develop coworkers as a subject matter expert
• Participate in client meetings, provide technical support, and lead projects across multiple disciplines.
• Support development of business strategies and new technologies for multiple customers across company sites.
• Collaborate with cross-functional teams to transfer and maintain processes in the facility.
• Work closely with manufacturing to author batch documentation and provide technical oversight for GMP manufacturing.
• Compile process data, communicate project status, identify trends, and deliver presentations.
• Evaluate existing processes and recommend improvements to enhance efficiency and consistency. Support building business cases for process improvement projects.
• Author and review documents including batch records, tech transfer reports, and engineering specifications.
• Lead technical support for risk assessments, gap analysis, deviations, change controls, and CAPAs.
• Oversee technical support of manufacturing, including technology transfer between external clients or process development and manufacturing.
• Collaborate with engineers and scientists to drive facility fit and technical transfer of mammalian biologic processes. Evaluate, align, and recommend equipment and process improvements.
• Support technology transfer of processes into manufacturing for both internal and external processes.

The Candidate

Minimum Requirements

• Bachelor's degree in a STEM discipline and more than 15 years of related experience, OR Master's degree in a STEM discipline and more than 12 years of related experience, OR Doctorate degree in a STEM discipline and more than 8 years of related experience.
• Experience in report and documentation skills.
• Experience with statistical techniques for data analysis and reporting.
• Direct personnel and organizational group management experience, including mentoring and training staff members cross-functionally.
• Experience in investigating and closing deviations, out-of-specification results, and corrective and preventive actions.
• Experience drafting and revising standard operating procedures, batch production records, and reports.
• Experience with operating and troubleshooting process equipment, including single-use systems and consumables.
• Subject matter expertise in upstream (mammalian cell culture) or downstream (e.g., depth filtration, chromatography, tangential flow filtration, viral filtration, bulk drug substance fill) manufacturing processes across current Good Manufacturing Practice biologics production scales.
• Experience in facility fit, process scaling, and technology transfer.
• Individual must be able to see, hear, read, and write clear English. Frequent sitting, standing, walking, reading of written documents, and use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds. Must comply with Environmental Health and Safety responsibilities.

Preferred Skills & Background

• Commercial or large-scale cell culture experience and equipment troubleshooting.
• Experience working on late-phase, process performance qualification, and commercial programs is a plus.

Why You Should Join Catalent

• Defined career path and annual performance review and feedback process.
• Diverse, inclusive culture.
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
• Competitive paid time off plus 8 paid holidays.
• Community engagement and green initiatives.
• Medical, dental, and vision benefits effective day one of employment.
• Tuition reimbursement.

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.

personal initiative. dynamic pace. meaningful work.