Senior Process Engineer - Manufacturing Sciences & Technology, Upstream

Catalent•Madison, WI

1d•Onsite

About The Position

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. 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. 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.