Process Engineer - Engineering
Core
Optimize biologics manufacturing processes, lead technical support for risk assessments and deviations, and drive continuous improvement in a GMP facility.
Role type
Senior IC process engineer (biologics manufacturing)
Builds
Biopharmaceutical drug substances using single-use systems for clinical production
Domain
Biopharmaceuticals / Biologics manufacturing
Required skills
Process optimization, root-cause analysis, change control management, validation testing, data trend analysis, SOP development, facility operations, automation engineering, single-use system management
Preferred skills
Cross-department project leadership, complex report creation, technology introduction, method transfer
Technologies
Single-use systems, GMP manufacturing equipment, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT)
Responsibilities
Evaluate existing processes to enhance efficiency and cost savings; Lead technical support for risk assessments, gap analysis, and corrective actions; Support drafting of User Required Specifications and qualification testing; Oversee manufacturing technical support and troubleshooting; Track and analyze data for compliance and continuous improvement.
Seniority
Mid-level, hands-on IC
