Engineer
Core
Support aseptic processing operations and drive continuous improvement for sterile fill-finish manufacturing of high-quality medicines.
Role type
Manufacturing Engineer (Sterile Fill-Finish)
Builds
Reliable supply of GMP-compliant drug products (syringes, vials, devices)
Domain
Biotechnology / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
formulation development, syringe/vial filling operations, process characterization, technology transfer, process validation, deviation resolution, root cause analysis, risk assessment, CAPA implementation, FMEA, aseptic processing expertise, lyophilization, visual inspection, GMP compliance
Preferred skills
Chemical Engineering background, project management, multi-functional team leadership, technical problem solving, complex concept communication
Technologies
aseptic processing equipment, fill-finish technologies, lyophilization systems, visual inspection tools
Responsibilities
Lead characterization studies and fill recipe development; resolve process deviations and conduct root cause analysis; implement CAPA and process improvements; collaborate with cross-functional teams on validation and tech transfer; support expansion projects and equipment user requirements; act as POC for drug product teams on site capabilities
Seniority
Mid-Senior, hands-on IC with leadership responsibilities
