Validation Engineer II - Site Based, Redmond, WA

Responsibilities Execute FUSE commissioning and validation for early clinical manufacturing, late-stage/commercial manufacturing, and/or PPQ campaign support. Generate and review validation lifecycle documentation (validation master plans, protocols, and reports). Develop Validation Master Plans with cross-functional teams; support validation execution and risk assessments. Lead development/implementation of validation templates and workflows. Support governance policies and related SOPs for FUSE commissioning. Support validation deviation resolution (troubleshooting and root cause analysis). Perform periodic review of qualified/validated FUSE across JUST WA sites. Support inspection readiness, Health Authority/Client audits, and corrective actions. Qualifications (Required) Bachelor’s degree in engineering science (or related) with at least 2 years relevant experience. Proven experience executing commissioning and validation of FUSE. Knowledge of GMP concepts/quality systems; science- and risk-based qualification standards. Knowledge of process equipment, utilities, operations, and engineering principles. Experience with quality risk management. Problem-solving/critical thinking; strong interpersonal/team skills. cGMP knowledge; experience writing manufacturing technical documents. Ability to manage timelines with external collaborators/vendors; strong quality focus and attention to detail. Preferred Biologics manufacturing process knowledge; process automation (e.g., DeltaV). Single-use technologies. Experience with DCS/BAS/PLC/SCADA/PI/MES; utilities/facilities and process/clean validation methodologies. Authority inspection/audit support involvement. Benefits discretionary annual bonus medical/dental/vision short- and long-term disability basic life insurance 401(k) match flexible work paid time off and paid holidays wellness and transportation benefits #J-18808-Ljbffr Scorpion Therapeutics