Senior Process Engineer Manufacturing Sciences & Technology, Upstream

Catalents Madison Wisconsin site is a stateoftheart biologics development and manufacturing facility supporting customers from research through early and midstage clinical production. Located at 726 Heartland Trail in Madison the approximately 102700squarefoot GMP facility specializes in mammalian cell line engineering drug substance biomanufacturing and biopharmaceutical development utilizing flexible singleuse systems to enable rapid scaleup and customization. The site is home to Catalents proprietary GPEx and GPEx Lightning technologies which are used to generate highyielding mammalian cell lines for biologic therapies and supports production scales ranging from 50 to 4000 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 Catalents global biologics network and Wisconsins growing life sciences ecosystem.

We have an opportunity for a Senior Process Engineer - Manufacturing Sciences & Technology Upstream Technology Transfer to join our team. This role supports technology transfer between process development and GMP manufacturing ensuring robust and compliant operations. You will work on process modeling facility fit assessments and authoring critical documentation. This position offers the chance to collaborate across functions and contribute to the success of biologics programs.

Shift: Monday-Friday 8am-5pm (compensated on-call rotation)
Location: Madison WI
100% Onsite

• Oversee technical support of Manufacturing including technology transfer between external clients or Process Development and Manufacturing.
• Collaborate with engineers scientists and colleagues to drive facility fit and technical transfer of mammalian biologic processes.
• Perform evaluation alignment and recommendation of equipment and process improvements.
• Support technology transfer of processes into manufacturing for both internally and externally developed processes.
• Develop and execute technical work plans and schedules independently using customer milestones and site performance standards.
• Review statements of work and ensure projects stay within scope.
• Author and approve technical documents such as protocols technology transfer reports operating procedures and batch production records.
• Review technical documents for accuracy thoroughness and regulatory compliance.
• Train coach and mentor others on technical development or business topics.
• Participate in client meetings offering technical support and leading projects as technical lead across multiple disciplines.
• Identify and recommend business opportunities on a project-specific basis.
• Work cross-functionally with Process Development Manufacturing Quality Assurance Quality Control Supply Chain Project Management Facilities and other departments to transfer and maintain processes.
• Support strategic alignment across Catalent Biologics sites and the Madison site.
• Work closely with manufacturing to author batch documentation and provide technical and strategic oversight for GMP manufacturing.
• Lead or support compilation of process data communicate project status identify trends and deliver presentations.
• Evaluate existing processes and identify process or equipment improvements to enhance efficiency and competitiveness.
• Support building business cases for process improvement projects.
• Author and review documents including batch production records tech transfer reports bill of materials process descriptions project reports engineering specifications and summary reports.
• Lead technical support for risk assessments gap analysis deviations change controls and CAPAs including root-cause analysis and corrective action identification.

• Associates degree in STEM with 12 years of related experience or Bachelors in STEM with 6 years or Masters with 4 years or Doctorate in STEM without formal industry experience.
• Experience in mRNA product development mRNA manufacturing protein therapeutics manufacturing and late stage/commercial manufacturing.
• Experience authoring revising and reviewing technical documentation including reports standard operating procedures and batch production records supported by statistical data analysis.
• Proven leadership experience managing and mentoring staff including cross-functional training and personnel development.
• Hands-on experience investigating resolving and closing deviations out-of-specification events change controls and CAPAs in a cGMP-regulated environment.
• Technical expertise in upstream biologics manufacturing processes (e.g. mammalian cell culture in vitro transcription) including facility fit process scaling and technology transfer across cGMP production scales.
• Operational engineering experience supporting late-phase PPQ and commercial programs including design onboarding qualification operation and troubleshooting of single-use systems and manufacturing equipment for biologics and molecular therapeutics.
• Physical requirements: Ability to see hear read and write clear English. Frequent sitting standing walking reading and computer use. Occasional stooping kneeling crouching bending carrying and grasping. Frequent lifting up to 10 pounds and occasional lifting up to 50 pounds. Must comply with EHS responsibilities.

• Subject Matter Expert on large-scale or commercial-scale biologics and mRNA manufacturing including mammalian cell culture and/or in vitro transcription in a GMP-regulated environment.

• Defined career path with annual performance reviews and feedback process.
• Diverse and 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 to help you finish your degree or start a new one.

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7000 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.

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