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

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.

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.

Qualifications

• 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.

This job description is intended to describe the general content of the job, and to identify the essential functions of and requirements for the performance of this job.  It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Because job requirements evolve with the changing needs of Just-Evotec Biologics business, this description is subject to change and may be modified at any time, whether formally or informally.

The base pay range for this position at commencement of employment is expected to be $111,360 to $152,425;  Base salary offered may vary depending on the individual’s skills, experience and competitive market value. Additional total rewards include 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.

Evotec (US) Inc. is an Equal Opportunity Employer.  All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.