Principal Engineer - Global MSAT, Site based, Redmond, WA

Role: Principal Process Engineer leading late-stage biologics process transfer and tech transfer activities within a global MSAT team, supporting clinical and commercial manufacturing. Responsibilities: oversee site-to-site tech transfer, develop and review process validation and control strategies, perform gap analyses and risk assessments, and support regulatory documentation and inspections. Manage technical transfer projects for phase III and commercial biologics, ensuring process robustness and compliance. Requirements: Bachelor's in engineering or related field with 12+ years (or 8+ with MS) of experience; expertise in downstream processes (chromatography, filtration), upstream processes (cell culture, perfusion), process validation, and GMP principles; experience with process lifecycle management, regulatory CMC document preparation, statistical analysis, and risk tools (FMEA). Preferred: mastery in upstream or downstream operations at bench-scale to commercial scale, experience leading external collaborations, and navigating global regulatory requirements. The role involves leadership, strategic thinking, and mentoring, with a site-based work setup and potential for managing junior engineers.