Sr Process Engineer

Role: Serve as the engineering SME for bioprocess systems (cell culture, harvest, purification, utilities), ensuring system qualification, reliability, and performance. Responsibilities: oversee system lifecycle management—including design, qualification, maintenance, deviation resolution, and decommissioning; lead system modifications, FAT, commissioning, and validation protocols; develop calibration/maintenance plans; lead deviation investigations; support capital projects as project manager up to $5M; interface cross-functionally to meet project and operational goals. Qualifications: Bachelor’s in Engineering; 3+ years in pharma/biotech manufacturing; experience supporting FDA-regulated processes, with knowledge of bioreactors, chromatography, filtration, CIP, utilities, and automation systems; EIT or PE preferred. High-Value: bioprocess systems, regulatory compliance, GMP environment, system validation, project management, and technical support for biotech manufacturing. WorkSetup: on-site in Brooklyn Park, MN, with up to 25% travel; includes PPE use, facility walkdowns, and occasional ladder/climb support.