Principal Process Engineer - Manufacturing Sciences & Technology, Upstream

Catalent Pharma Solutions; Alabama; On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Career growth

Paid time off

Health benefits

Tuition reimbursement

Job summary

Catalent is seeking a Principal Process Engineer for Manufacturing Sciences & Technology to provide on-call and on-the-floor technical support for GMP manufacturing. The role involves drafting and reviewing documents, compiling data, and guiding investigations and change controls.

It is client-facing and partnership-driven across multiple teams. The candidate will lead technical projects, mentor staff, and drive process improvements, with a focus on mammalian biologics and single-use systems.

Qualifications

• Experience with report/documentation workflows in GMP environments.
• Strong data analysis and statistics background.
• Experience leading cross-functional teams and mentoring staff.
• Proven ability to investigate deviations and CAPAs.
• Proficiency drafting SOPs, batch records, and tech transfer docs.
• Hands-on experience with mammalian cell culture processes and upstream/downstream technologies.

Responsibilities

• Develop and execute technical work plans for multiple projects.
• Author and review protocols, tech transfer reports, and batch records.
• Lead investigations, deviations, and CAPAs with cross-functional teams.
• Mentor and coach colleagues; contribute to project strategy and tech transfer.
• Support GMP manufacturing with technical oversight and process improvements.

Skills

Report and documentation skills

Statistical techniques

Mentoring staff

Deviation investigations

SOP drafting/revision

Process equipment operation

Upstream/downstream manufacturing

Education

Bachelor's degree in STEM

Master's or Doctorate in STEM

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 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. Visit Catalent Careers to explore career opportunities.

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

Volunteer Work Disclosure: Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis.

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.

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.