Senior Process Engineer - Manufacturing Sciences & Technology, Upstream

Catalent Pharma Solutions • Madison, WI

2d • Onsite

About The Position

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.

Requirements

• Associate’s degree in STEM with 12+ years of related experience, or Bachelor’s in STEM with 6+ years, or Master’s 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.
• 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.

Nice To Haves

• 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.

Responsibilities

• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Associate degree