Downstream Maintenance Leader IFB
Core
Manage project control activities for the End To End Insulin Flex Facility project, overseeing design phases, construction support, and the transition to routine operations for a new Chinese manufacturing site.
Role type
Senior IC maintenance leader (project execution)
Builds
Greenfield infrastructure, maintenance/calibration strategies, SOPs, and autonomous production units for insulin manufacturing
Domain
Healthcare / Biologics / Industrial Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Maintenance & Calibration management, GMP/FDA/EU guidelines knowledge, Master data and CMMS processes implementation, FAT/SAT/commissioning support, local outsourcing strategy, team building and talent empowerment, regulatory compliance (HSE), technical reviews (URS, P&IDs, HAZOP, 3D models)
Preferred skills
Experience in large complex matrix environments, innovation in working methods
Technologies
iShift program, CMMS, 3D modeling tools
Responsibilities
Collaborate on design reviews (URS, P&IDs, HAZOP, 3D models), design and deliver local outsourcing strategies for maintenance, lead replication of technical activities and SOPs, implement master data and CMMS processes, support FATs, commissioning, SAT, and start-up, build high-performance internal and external teams
Seniority
Senior, hands-on IC