Catalent, Inc.
Biologics
ProcessEngineer-ManufacturingSciences&Technology(MS&T),DownstreamTechnologyTransfer
Neural analysis suggests this role is
optimal for Mid candidates.
“Process Engineer - Manufacturing Sciences & Technology (MS&T), Downstream Technology Transfer at Catalent, Inc.. Skills: Downstream Tech Transfer, biologics manufacturing processes, technology transfer, GMP manufacturing, technical documentation authoring. 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”
What You'll Achieve.
successful transfer and execution of biologic processes; enable robust, compliant, and scalable manufacturing operations; enhance efficiency, consistency, and operational competitiveness
Industry & Context.
root cause analysis; impact assessment; troubleshooting of single-use systems, consumables, and manufacturing equipment
100% on-site (Madison, WI), 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 EHS responsibilities
What They're Looking For.
Must Have
Associate's degree in STEM with 6+ years of related experience, mRNA product development experience, mRNA manufacturing, protein therapeutics MFG, 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 commercial programs, including design, onboarding, qualification, operation, and troubleshooting of single‑use systems, consumables, and manufacturing equipment for biologics and molecular therapeutics, Must be able to see, hear, read, and write clear English
Nice to Have
Bachelor’s and/or Master’s with at least 3+ years of related experience
What You'll Do.
Provide technical support to Manufacturing
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
and GMP manufacturing programs
and review technical documentation
including development reports
technical transfer reports
batch production records
engineering specifications
Conduct parallel technical reviews of laboratory and engineering documentation to ensure accuracy
and regulatory compliance
Support GMP manufacturing through technical oversight
batch documentation authoring
and close collaboration with Manufacturing teams
Lead or support risk assessments
including root cause analysis and impact assessment
Evaluate existing processes and identify process or equipment improvement opportunities to enhance efficiency
and operational competitiveness
and communicate process and project data
including status reporting
and internal or client-facing presentations
and coach junior staff on laboratory
Serve as a subject matter expert
How You'll Work.
Team & Collaboration
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
Communication Scope
talking; listening; client-facing presentations; client meetings
Process & Methodology
Execute technical work plans and schedules
Full Job Description
**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 develo
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