Engineer I
Core
Technical process and system owner for Central Manufacturing Services (CMS), driving continuous improvement, change management, and operational reliability for biopharmaceutical manufacturing processes.
Role type
Manufacturing Engineer (Process & Systems)
Builds
CMS processes including Media and Buffer preparation, Autoclave operations, Column Packing, and Automated Logistics
Domain
Biopharmaceutical manufacturing / GMP-regulated environment
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process optimization, Change control management, Root cause analysis, Data analysis, Risk assessment (FMEA), Lean/Six Sigma methodologies, Equipment reliability management, GMP compliance, Technical writing
Preferred skills
Single use Systems experience, Deviation investigation, Equipment troubleshooting, Process data analytics
Technologies
Autoclave systems, Column packing systems, Automated logistics systems, Single use Systems
Responsibilities
Own technical integrity and performance of assigned CMS processes and equipment; Lead continuous improvement initiatives using Lean/Six Sigma; Drive change controls for process and equipment modifications; Lead root cause analysis and CAPA for process deviations; Ensure GMP, EHS, and data integrity compliance; Support NPI and process startup activities.
Seniority
Mid-level IC (3-5 years experience)
