Process Engineer - Engineering
Core
Process Engineer supporting biologics development and manufacturing, focusing on process optimization, technical troubleshooting, and validation testing for mammalian cell line engineering and drug substance biomanufacturing.
Role type
Process Engineer (Biologics Manufacturing)
Builds
Biopharmaceutical drug substances and cell lines for clinical production
Domain
Biopharmaceuticals / Biologics Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process optimization, risk assessment, root-cause analysis, change control, deviation management, validation testing, data analysis, SOP development, single-use system management
Preferred skills
Cross-department project leadership, complex reporting, trend analysis, technology introduction, method transfer
Technologies
GPEx, GPEx Lightning, single-use systems, GMP manufacturing equipment
Responsibilities
Evaluate existing processes to enhance efficiency and cost savings; Lead technical support for risk assessments, gap analysis, deviations, and corrective actions; Support drafting of User Required Specifications and participate in Factory/Site Acceptance Testing; Oversee technical support of Manufacturing including troubleshooting; Track and analyze data for compliance and product quality; Manage consumable and raw material lifecycle for single-use GMP manufacturing
Seniority
Mid-level, hands-on IC
