Process Engineer - Manufacturing Sciences & Technology, Upstream

Catalent Pharma Solutions•Madison, WI

2d•Onsite

About The Position

We have an opportunity for a Process Engineer - Manufacturing Sciences & Technology, Upstream Technology Transfer to join our team. This role supports technology transfer and process readiness for biologics manufacturing. You will work closely with cross-functional teams to ensure successful transfer and execution of upstream processes. The position offers the chance to contribute to innovative projects in a dynamic, GMP-regulated environment.

Requirements

Minimum of Associate’s degree in STEM with 6+ years of related experience, or Bachelor’s and/or Master’s with at least 3+ years of related 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 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, out-of-specification events, change controls, and CAPAs in a cGMP-regulated environment.
Technical subject matter expertise in upstream (e.g., mammalian cell culture, in vitro transcription) and/or downstream biologics manufacturing processes (e.g., filtration, chromatography, tangential flow filtration, viral filtration), including facility fit, process scaling, and technology transfer across cGMP production scales.
Operational engineering experience supporting late-phase, process performance qualification, and commercial programs, including design, onboarding, qualification, operation, and troubleshooting of single-use systems, consumables, 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 Environmental Health and Safety responsibilities.

Nice To Haves

Subject matter expertise on large scale/commercial scale biologics and mRNA manufacturing (including mammalian cell culture and/or in vitro transcription) in GMP-regulated environment.

Responsibilities

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 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.