Process Engineer - Manufacturing Sciences & Technology

About 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