M&S - IFB - Downstream Maintenance Lead
Core
Lead downstream process (DSP) maintenance for a new greenfield insulin manufacturing facility in Beijing, managing design, commissioning, and daily operations of chromatography, crystallization, and drying systems.
Role type
Senior IC maintenance lead (pharmaceutical biologics)
Builds
Fully automated insulin drug substance production facility
Domain
Pharmaceutical manufacturing / Biologics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
downstream process equipment maintenance, GMP compliance, preventive maintenance planning, troubleshooting, spare parts inventory management, HAZOP/HAZID analysis, technical documentation, cross-functional collaboration
Preferred skills
experience with chromatography/crystallization/drying equipment, knowledge of Chinese local codes and regulations, English technical communication
Technologies
P&IDs, 3D models, FAT/SAT tools, maintenance software, office software
Responsibilities
Manage DSP maintenance activities from basic engineering to detailed design; oversee daily maintenance, PM, troubleshooting, and emergency repairs; participate in FAT, commissioning, and qualification activities; drive design and implementation of maintenance activities ensuring GMP compliance; oversee spare parts inventory and procurement; coordinate with internal teams and external vendors.
Seniority
Senior, hands-on IC