Quick overview
SeniorityMid Senior
Employment typeFull Time
Work modeOn Site
LocationBend, United States
Posted7 months ago
Job description
Serán is seeking a hands-on Process Engineer with deep spray drying expertise to develop, scale, and transfer robust processes for small molecule and complex drug products. You will lead end-to-end unit operations—from feasibility and DOE through clinical/commercial scale-up—while ensuring safety, quality (GMP), and operational excellence in a fast-paced, collaborative environment.
As the system owner, the Process Engineer oversees creation and revision of equipment documentation packages, supports regulatory and client audits, and ensures alignment with cGMP expectations. They maintain a deep, data‑driven understanding of equipment performance, analyze trends to anticipate issues, and drive improvements that enhance reliability, yield, and product quality. The role collaborates closely with Maintenance, Quality, Validation, and Manufacturing to coordinate spare‑parts strategies, preventative maintenance, calibration schedules, and implementation of clean‑in‑place systems. In a CDMO setting, the engineer also partners with clients and internal teams to support tech transfers, scale‑up activities, and lifecycle management of spray‑drying processes.
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