Validation Engineer II - Redmond / Seattle, WA, Site Based

Validation Engineer II

At Just Evotec Biologic, 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 encouragedit's celebrated.

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

We're looking for a passionate and curious Validation Engineer II 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 Validation Engineer II at Just Evotec Biologic, 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.

The primary focus of this job is to support manufacturing and laboratory equipment, systems, facilities, and utilities commissioning, qualification and validation activities required in early phase manufacturing to late-stage programs into PPQ / commercial biologics manufacturing. These responsibilities span all phases of the lifecycle from system implementation and qualification to cleaning and shipping validation. This role will also work cross functionally and collaborate with other teams on validation projects.

What You'll Do :

• Execute FUSE commissioning and validation activities for early stage clinical manufacturing, late-stage molecule / commercial manufacturing and / or PPQ campaign support.
• Generate and review technical documentation including validation lifecycle documents, validation protocols and associated reports related to the equipment validation lifecycle.
• In collaboration with cross functional teams, develop Validation Master Plans, provide process knowledge to support the validation execution and risk assessments.
• Lead the development and implementation of templates and validation workflows.
• Support the generation of governance policies and related SOPs for commissioning of FUSE.
• Support validation deviation resolution including troubleshooting and root cause analysis
• Support the periodic review of qualified / validated FUSE across JUST WA sites.
• Support inspection readiness activities, Health Authority and Client audits, and support corrective actions based on audit findings

Who You Are :

Additional Preferred Qualifications :

Why Join Us :

Are You Still Curious?

If you've read this far, then chances are you've got a curious mindjust like us. So, what are you waiting for? Take the leap and apply today. We can't wait to see where your curiosity leads youand how it will shape the future of Just Evotec Biologic.

Let your curiosity guide your career #BeCurious and explore the endless possibilities at Just Evotec Biologic!

The base pay range for this position at commencement of employment is expected to be $79,800 to $109,250; 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.