Quality Engineer - Site based either Redmond or Seattle, WA

Role Summary

Quality Engineer, QEV at Just Evotec Biologics, site-based in Redmond, WA or Seattle, WA. Responsible for quality systems, validation activities, and collaboration with internal/external partners to ensure GxP compliance and effective qualification/validation of equipment and processes.

Responsibilities

• Apply knowledge of technical and validation standards to influence interpretation of governing requirements related to Quality Systems and Validation.
• Understand and oversee the equipment management program to ensure manufacturing equipment is in a state of control, including reviewing and approving calibration and preventive maintenance documents.
• Provide Quality oversight and approval of installation, qualification/validation, operation and maintenance of GxP equipment and computerized systems, including infrastructure qualification.
• Mentor functional groups in qualification/validation technical aspects and compliance requirements.
• Collaborate with internal/external collaborators, vendors, and regulatory agencies to anticipate and resolve quality issues and maintain GxP compliance.
• Perform risk assessments and data integrity evaluations in support of validation/qualification activities.
• Travel to JEB sites as required; onsite support at Redmond or Seattle facility depending on site needs.

Qualifications

• Required: Bachelor’s degree in biological sciences, chemistry, biochemistry, engineering, computer science or related life science field.
• Required: 4+ years of relevant experience in a biopharmaceutical cGMP manufacturing or similar environment.
• Required: Knowledge of Risk Management, Data Integrity, Industry guidelines, US & EU regulatory requirements.

Skills

• Quality systems and validation planning
• GxP equipment qualification and calibration
• Data integrity and risk assessment
• Regulatory guidelines knowledge (US & EU)
• Cross-functional collaboration and effective communication

Education

• Bachelor’s degree in a life sciences or related field (as listed in qualifications)

Additional Requirements

• Travel to sites as needed; onsite support at Redmond or Seattle facility based on site needs.