Process Engineer II
Core
Own and investigate manufacturing non-conformances to ensure on-time product delivery and support R&D piloting efforts.
Role type
Process Engineer II (Manufacturing Technical Operations)
Builds
Medical diagnostic devices and testing tools
Domain
Life sciences, diagnostics, biotechnology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
root cause investigation, problem solving, corrective and preventative actions, technical writing, analytical testing (HPLC, UV-Vis Spectroscopy, bioassay), Design of experiments, risk-based technical justifications
Preferred skills
Hands-on laboratory experience in Microbiology, Danaher Business System, Lean/Kaizen/6-sigma, PSP, Risk management, process validation, design change
Technologies
HPLC, UV-Vis Spectroscopy, bioassay
Responsibilities
Resolve Internal Non-conformance investigations, Provide technical support for Operations, Support Factory OTD and schedule attainment, Lead and resolve customer manufacturing related CAPA and PLRA, Support manufacturing of pilot runs and troubleshoot deviations
Seniority
Mid-level, hands-on IC
