Process Engineer

Role: Serve as the engineering subject matter expert for biopharmaceutical manufacturing support, focusing on process systems such as cell culture, harvest, purification, or utilities. Responsibilities: oversee system lifecycle from design, qualification, to maintenance; develop engineering deliverables (PFDs, P&IDs, specifications); lead system modifications, FATs, commissioning, and CAPA investigations; support system qualification, asset management, and project execution; ensure compliance with cGMP and GEP standards; potentially serve as project manager for small capital projects. Requirements: Bachelor's degree in Engineering (Chemical preferred), with 0+ years of engineering experience, ideally within regulated biopharma or biotech manufacturing; familiarity with bioreactors, chromatography, CIP, HVAC, and automation systems; knowledge of GMP and industry best practices; proficiency in MS Office and project management tools. Preferred: Engineer-in-Training (EIT) or Professional Engineer (PE) licensure; experience with FDA-regulated processes and biopharmaceutical equipment. High-Value: Focus on manufacturing systems supporting biologics or cell/gene therapies, with emphasis on qualification, maintenance, and process support in a regulated environment. Collaboration: Partner with cross-functional teams across manufacturing, quality, and engineering. Work setup: Primarily on-site at Brooklyn Park, MN, with infrequent travel (~25%) and participation in 24/7 on-call support rotation. The role demands adherence to strict safety and quality protocols, including PPE usage.