Validation Engineer II - Site , 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.

• 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.

• Biologics manufacturing process knowledge; process automation (e.g., Delta
  
  V).
• Single-use technologies.
• Experience with DCS/BAS/PLC/SCADA/PI/MES; utilities/facilities and process/clean validation methodologies.
• Authority inspection/audit support involvement.

• 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