Quality Engineer - Site based either Redmond or Seattle, WA
Evotec
Full-time
Remote friendly (Redmond, WA)
United States
Operations
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Role Summary
Quality Engineer, QEV at Just Evotec Biologics. Site-based role in Redmond, WA or Seattle, WA. Focused on quality systems, validation, and equipment qualification to support gXp manufacturing in a biopharmaceutical environment.
Responsibilities
- Apply knowledge of technical and validation standards to influence interpretation of requirements related to Quality Systems and Validation.
- Understand 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 and provide onsite support at Redmond or Seattle facilities 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, and US/EU regulatory requirements.
Skills
- Quality systems, validation, risk assessment, data integrity, and regulatory compliance.
- Cross-functional collaboration and vendor/regulatory interaction.
Education
- Bachelor’s degree as listed in Qualifications.
Additional Requirements
- Travel to JEB sites as required; onsite support at Redmond or Seattle facility depending on site needs.