Catalent
Madison, WI
Shift: Full time
Process Engineer - Manufacturing Sciences Technology (MS T), Downstream Technology Transfer Position Summary: Work Schedule: Monday – Friday, core hours 8am-5pm 100% on-site (Madison, WI) Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO). Located in Madison, WI, this facility features advanced mammalian cell line engineering and biomanufacturing capabilities using single-use systems to support scalable production. This 263,000 sq. ft. Good Manufacturing Practice (GMP) facility offers integrated formulation and analytical services to address complex development challenges in Biologics. The Process Engineer for MS T supports the department which serves as an agile technical services organization supporting process and technology transfer between Process Development (internal and external) and at‑scale GMP manufacturing. The Technology Transfer groups (Upstream and Downstream) act as the primary technical liaisons, ensuring successful transfer and execution of biologic processes across a range of modalities, including monoclonal antibodies, fusion proteins, enzymes, mRNA, and emerging technologies. Department responsibilities include process modeling, facility fit assessments, initial bill‑of‑materials development, and evaluation of equipment and consumables, as well as authoring and supporting critical manufacturing documentation such as gap assessments, technical reports, product impact assessments, and batch records. MS T also provides hands‑on process readiness and execution support to enable robust, compliant, and scalable manufacturing operations. The Role: Downstream Tech Transfer Duties: Provide technical support to Manufacturing, leading facility fit, equipment alignment, and technology transfer of biologic processes from Process Development and external clients. Evaluate and recommend process and equipment improvements while supporting technology transfer for both internally and externally developed manufacturing processes. Execute technical work plans and schedules, including data generation and entry, in collaboration with supervisors or senior team members. Perform engineering and process calculations to support development, tech transfer, and GMP manufacturing programs. Draft, author, and review technical documentation, including development reports, technical transfer reports, batch production records, engineering specifications, and summary reports. Conduct parallel technical reviews of laboratory and engineering documentation to ensure accuracy, completeness, and regulatory compliance. Support GMP manufacturing through technical oversight, batch documentation authoring, and close collaboration with Manufacturing teams. Lead or support risk assessments, gap analyses, deviations, change controls, and CAPAs, including root cause analysis and impact assessment. Evaluate existing processes and identify process or equipment improvement opportunities to enhance efficiency, consistency, and operational competitiveness. Compile, analyze, and communicate process and project data, including status reporting, trend analysis, and internal or client-facing presentations. Partner cross-functionally with Process Development, Manufacturing, Quality Assurance, Quality Control, Supply Chain, Project Management, Facilities, and other stakeholders to enable effective process transfer and sustainment. Support strategic alignment and knowledge sharing across sites, including coordination with Madison and other Catalent Biologics locations. Participate in client meetings, providing technical expertise and program support. Train, mentor, and coach junior staff on laboratory, manufacturing, and engineering principles; serve as a subject matter expert. Other duties as assigned The Candidate: Must have a minimum of Associate’s degree in STEM with 6 years of related experience. It is preferred to have a Bachelor’s and/or Master’s with at least 3 years of related experience. Related experience encompasses mRNA product development experience, mRNA manufacturing, protein therapeutics MFG, and late stage/commercial MFG. Demonstrated experience authoring, revising, and reviewing technical documentation, including reports, standard operating procedures (SOPs), and batch production records, supported by statistical data analysis and reporting. Proven leadership experience managing and mentoring staff, including cross‑functional training, personnel development, and organizational team support. Hands‑on experience investigating, resolving, and closing deviations, OOS events, change controls, and CAPAs in a cGMP-regulated environment. Technical subject matter expertise in upstream (e.g., mammalian cell culture, IVT) and/or downstream biologics manufacturing processes (e.g., filtration, chromatography, TFF, viral filtration), including facility fit, process scaling, and technology transfer across cGMP production scales. Operational engineering experience supporting late‑phase, PPQ, and com