Process Engineer
Core
Design and execute single-use customized hardware projects and consumables for biopharmaceutical upstream and downstream processes.
Role type
Process Engineer (Customer Engineering)
Builds
Single-use mixing, storage, bulk filling, and filtration systems for biopharmaceutical manufacturing.
Domain
Biopharmaceutical manufacturing / Single-use technology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Biopharmaceutical process knowledge, Single-use technology hardware design, Process and instrumentation diagram creation, Project costing, Supplier quotation analysis, FAT/SAT qualification coordination, Cross-functional project management
Preferred skills
System concept design, Hardware validation experience, Qualification activities for process equipment
Technologies
Single-use mixing bags, storage bags, filtration manifolds, final filling manifolds, transfer sets, bioreactor, filtration, separation and purification equipment
Responsibilities
Analyze customer user requirements and define technical solutions including equipment selection and sizing, Create project costing sheets and request/analyze quotations from sub-suppliers, Complete basic design including P&IDs and process functional specifications, Coordinate cross-functional activities with mechanical, electrical, and software fabricators, Execute and coordinate Qualification/Verification activities (pre-FAT, FAT, SAT, IV/OV), Assess and resolve complex technical/process issues
Seniority
Mid-level, hands-on IC
