Process Engineer
Core
Support technology transfer and production of BMS CAR-T products for clinical trials and commercial supply, ensuring compliant, cost-effective delivery.
Role type
Process Engineer (Cell Therapy Manufacturing)
Builds
CAR-T cell therapy products for global clinical trials and commercial supply
Domain
Biopharmaceuticals / Cell Therapy
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process optimization, deviation resolution, change control management, troubleshooting, cGMP operations, root cause analysis, CAPA execution, single-use technologies, closed systems, cold chain/cryogenic technologies, facility/clean room design, automation, start-up and process transfer
Preferred skills
Advanced degree in science or engineering, MSAT experience, manufacturing support experience, process development experience
Technologies
Single-use technologies, closed systems, cold chain/cryogenic technologies, MSAT MES, MSAT PDDA
Responsibilities
Monitor and optimize end-to-end production processes, provide technical input for process deviations, author and review technical documentation (SOPs, batch records, investigations), interact with shop floor operations during production campaigns, support change initiatives and process improvements, participate in technology transfer into the Leiden facility, work in shifts to support manufacturing operations, interact with cross-functional teams (QA, Supply Chain, Engineering), support regulatory inspections, execute test plans and risk mitigation exercises
Seniority
Mid-level, hands-on IC
