Quality Engineer - Site based either Redmond or Seattle, WA
About The Position
We’re looking for a passionate and curious Quality Engineer, QEV to join our team. If you’re excited by new challenges, solving complex problems, and learning every step of the way, you might just be the perfect fit. In this role, you’ll have the opportunity to drive impactful projects, collaborate with bright minds, and explore uncharted territories. As a Quality Engineer, QEV at Just Evotec Biologics, you'll have the freedom to ask the hard questions, think outside the box, and find creative solutions that push us forward. It’s a role where your curiosity will fuel both your personal growth and the success of the team.
Requirements
- 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.
- 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.
- Travel to JEB sites as required.
- Onsite support at Redmond or the Seattle facility depending on site needs.
Benefits
- Growth Opportunities
- Flexible Work Environment
- Inclusive Culture
- Innovative Projects
- A Place for Big Ideas
- discretionary annual bonus
- comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
51-100 employees
