Staff Engineer, Advanced Operations
Core
Lead technical leadership for biologics process development, validation, and manufacturing readiness to support new product introductions.
Role type
Staff Engineer, Advanced Operations (Biologics Process Development)
Builds
Biologics manufacturing processes and product launches
Domain
Healthcare / Biologics Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Biologics process development, Process validation, Statistical analysis, Equipment qualification, PFMEA development, Control plan creation, SOP development, GD&T interpretation, DFM, Process capability studies, MSA
Preferred skills
FDA-regulated industry experience, ISO 13485-regulated industry experience, Global supply chain management
Responsibilities
Lead development and optimization of upstream and downstream biologics manufacturing processes; Conduct process characterization and worst-case condition studies; Evaluate and qualify manufacturing equipment and components; Generate technical documentation including PFMEAs, Control Plans, and validation protocols; Mentor engineers and provide technical guidance to stakeholders.
Seniority
Staff, technical leadership & mentorship
