Sr. Quality Validation Engineer - Site based, Redmond and Seattle, WA

Just Evotec Biologics • Redmond, WA

256d • $111,360 - $152,425

About The Position

The Senior Quality Engineer, QEV for the Redmond and Seattle sites reports to the Sr. Manager QEV. This position is responsible for providing technical and quality oversight of all qualification and validation activities, ensuring that the program and execution are fully compliant with the Just Pharmaceutical Quality System (PQS) and regulations. This role will partner to build, provide guidance, and develop solutions to complex system qualification and validation efforts. Note: This role will be working between sites Redmond and Seattle to suit the business needs. Monday to Fridays, 8:00am till 5:00pm, some flexibility on start times.

Requirements

• Bachelor's degree in biological sciences, chemistry, biochemistry, engineering, computer science or related life science field.
• 6+ years relevant experience in a biopharmaceutical cGMP manufacturing or similar environment.
• Be able to successfully work independently and within teams, demonstrate strong problem-solving skills, partner/customer focus, and the ability to work with complex business systems and processes.
• 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 local sites as required.

Benefits

• Discretionary annual bonus
• Comprehensive benefits including 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Warehousing and Storage
• Education Level: Bachelor's degree