Just Evotec Biologics is looking for a Quality Engineer, QEV to drive impactful projects, collaborate with bright minds, and explore uncharted territories by applying knowledge of technical & validation standards/requirements and industry guidance to influence the interpretation of governing requirements as it relates to Quality Systems & Validation.
Requirements
- Knowledge of Risk Management, Data Integrity, Industry guidelines, US & EU regulatory requirements.
Responsibilities
- Apply knowledge of technical & validation standards/requirements and industry guidance to influence the interpretation of governing requirements as it relates to Quality Systems & Validation.
- Understand JEB equipment management program to ensure manufacturing equipment is in a state of control, including reviewing and approving equipment calibration and preventative maintenance documents.
- Provide Quality oversight and approval of the 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.
- Partner with both internal/external collaborators, vendors, and regulatory agencies to anticipate and resolve quality issues as well as maintain GxP compliance.
- Perform risk assessments and data integrity evaluations in support of validation/qualification activities.
Other
- Bachelor’s degree in biological sciences, chemistry, biochemistry, engineering, computer science or related life science field.
- 4+ years relevant experience in a biopharmaceutical cGMP manufacturing or similar environment.
- Travel to JEB sites as required.
- Onsite support at Redmond or the Seattle facility depending on site needs.
- Curiosity is the spark that drives innovation and success.
