Process Engineer, Principal Scientist – Automation of Machinery and Processes
Core
Lead cross-functional workstreams for equipment & systems development, process optimization, and technology transfer to deliver robust and reliable manufacturing systems for Cell & Genetic Therapies.
Role type
Principal Process Engineer (Automation of Machinery and Processes)
Builds
Manufacturing systems and equipment for Cell & Genetic Therapy programs
Domain
Biotechnology / Cell & Genetic Therapy / Manufacturing Automation
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process & Systems Engineering, cGMP/cGxP principles, FMEA, root cause analysis, CAPA, change control, vendor management, technical writing, risk assessment, Lean/Six Sigma
Preferred skills
Cell & genetic therapy experience, Lean/Six Sigma Green Belt, DMAIC
Technologies
URS/FRS development, facility & systems simulation, FAT/SAT execution
Responsibilities
Design and lifecycle management of process equipment, lead equipment development from concept to implementation, troubleshoot critical manufacturing issues, author and approve technical documentation, mentor junior engineers, lead deviation and CAPA investigations
Seniority
Principal, hands-on IC with strategic influence