Sr. Quality Engineer - Site based, Redmond, WA
Sr. Quality Engineer - Site based, Redmond, WA
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
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 whats possible. Were on a mission to create a place where curiosity isnt just encouragedits celebrated.
Are you someone who asks questions seeks answers and isnt afraid to go deeper #BeCUREious with us and see where your curiosity can take you!
The Role: Your challenge in our journey
Were looking for a passionate and curious Senior Quality Engineer QEV to join our team. If youre excited by new challenges solving complex problems and learning every step of the way you might just be the perfect fit. In this role youll 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 youll have the freedom to ask the hard questions think outside the box and find creative solutions that push us forward. Its a role where your curiosity will fuel both your personal growth and the success of the team.
What Youll 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 ofvalidation/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:
Bachelors 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: Were a company that believes in continuous learning and development. Whether its professional courses mentorship or new projects well help you grow.
Flexible Work Environment: We offer flexible work options to help you balance your professional and personal life whether that means working remotely or choosing a hybrid model.
Inclusive Culture: Were committed to building a diverse and inclusive environment where everyones voice is valued and curiosity is encouraged.
Innovative Projects: Youll have the chance to work on groundbreaking initiatives and cutting-edge technology in an atmosphere where your curiosity is the key to success.
A Place for Big Ideas: We dont just talk about thinking outside the boxwe throw the box away. If youve got ideas we want to hear them.
Are You Still Curious
If youve read this far then chances are youve got a curious mindjust like us. So what are you waiting for Take the leap and apply today. We cant wait to see where your curiosity leads youand how it will shape the future of Just Evotec Biologics
Let your curiosity guide your career#BeCUREious and explore the endless possibilities at Just Evotec Biologics!
The base pay range for this position at commencement of employment is expected to be $77000 to $126000; Base salary offered may vary depending on the individuals 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.
Required Experience:
Senior IC
Employment Type
Full-Time
