Engineer 2 - Process Development • Manufacturing Technology & Transfer Dept
Core
Develop and deploy reagent formulation, fill, and assembly processes for consumable genomic sequencing products in pilot plant and manufacturing environments.
Role type
Process Engineer (Manufacturing Technology & Transfer)
Builds
Consumable products for genome sequencing (reagents, fill, assembly)
Domain
Biotechnology / Genomics / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP best practices, process development, scale-up, process improvement, quality engineering, equipment validation, statistical process control, DOE techniques, high-volume production management, cross-functional project leadership
Preferred skills
cGMP, 21CFR820, ISO 13485, ISO 14971, lyophilization cycle development, excipient and formulation development, liquid handling automation (Hamilton Robotics, Tecan), 6-sigma, DFSS, 8D, DMAIC
Technologies
Hamilton Robotics, Tecan, lyophilization equipment, production equipment sourcing
Responsibilities
Define technical requirements for manufacturing processes and new production equipment; Author procedures and instructions for new manufacturing processes; Design, develop, and source production equipment from vendors; Troubleshoot new product and manufacturing process issues related to yield, quality, and throughput; Execute controlled experiments and DOE's to optimize processes; Analyze process test results and make technical recommendations; Ensure successful transfer of knowledge into manufacturing and sustaining support teams
Seniority
Mid-level IC (2-4 years experience)