Scientist III, operation
Core
Process Engineer / Scientist III supporting cGMP/GRP biopharmaceutical manufacturing operations in Suzhou, focusing on process support, troubleshooting, validation, and continuous improvement.
Role type
Senior IC process engineer (biopharmaceutical manufacturing)
Builds
cGMP/GRP production line operations for biologics/life sciences products
Domain
Biopharmaceuticals / Regulated Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, process troubleshooting, technical documentation, validation support, change control, root cause analysis, cross-functional collaboration, data analysis
Preferred skills
cell culture media/buffers/reagents experience, tech transfer/scale-up support, SAP/MES/LIMS familiarity, Lean/continuous improvement tools, audit support
Technologies
SAP, MES, LIMS, electronic documentation systems
Responsibilities
Provide daily technical support for cGMP manufacturing operations including process monitoring and troubleshooting; Support process transfer, scale-up, startup, and operational readiness; Prepare and update technical documents (SOPs, protocols, reports, risk assessments); Support validation activities (process, equipment, cleaning); Investigate deviations and implement CAPA actions; Analyze process data to generate trends and optimization recommendations; Support training for manufacturing personnel on process topics.
Seniority
Senior, hands-on IC