Sr. Quality Engineer - Site based, Redmond, WA

Job Title: Quality Engineer, QEV    

Location: Redmond, WA with travel to Seattle, WA site

Department: Manufacturing

Reports To: Sr. Manager QEV

About Us: this is who we are

At Just Evotec Biologics, we believe that curiosity is the spark that drives innovation and success. As a forward-thinking team, we thrive on challenging the status quo, learning from each other, and pushing the boundaries of what’s possible. We're on a mission to create a place where curiosity isn't just encouraged—it’s celebrated.

Are you someone who asks questions, seeks answers, and isn't afraid to go deeper?   #BeCUREious with us and see where your curiosity can take you!

The Role: Your challenge …in our journey

We’re looking for a passionate and curious Senior 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 Senior 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.

What You’ll Do:

• Apply extensive 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.

• Review/approve Maintenance Work Orders, Non-conformance Discrepancies and Change Controls related to Qualification, Validation, Engineering and Maintenance of Facility, Utilities, Equipment and computerized systems.

• Review and approve qualification/validation documents, before and after execution, as required.

• Apply knowledge of GMP computerized systems, qualification and validation principles, manufacturing processes, quality systems, engineering design fundamentals, health authority expectations and industry standards

• Provide oversight to the overall site validation master plan, including interactions with other Just-Evotec entities responsible for related non-site-based computer systems.

• Travel to JEB sites as required. Onsite support at Redmond or the Seattle facility depending on site needs.

Who You Are:

• Bachelor’s degree in biological sciences, chemistry, biochemistry, engineering, computer science or related life science field.

• 6-10+ years relevant experience in biopharmaceutical cGMP manufacturing, Validation or in medical devices with a life science or or similar environment/background. 

• Sound knowledge of Risk Management, Data Integrity, cGMPs and guidelines set forth in Annex 15, 21 CFR Part 210 and 211, ICH Q8, 9, 10, and ISPE Commissioning and Qualification Baseline Guide.

• Knowledge of the Drug Substance manufacturing process and process (equipment) systems in the biopharmaceutical industry as well as key business processes including review by exception, electronic batch production records/batch reports, materials management, and sample management in the pharmaceutical industry.

• Experience with health authority inspections demonstrating their expertise and the successful defense of qualification and validation strategies.

Why Join Us:

• Growth Opportunities: We’re a company that believes in continuous learning and development. Whether it’s professional courses, mentorship, or new projects, we’ll help you grow.

• Flexible Work Environment: We offer flexible wor