Validation Engineer II - Site based Redmond, WA

Job Title: Validation Engineer II

Location: Redmond, WA                                                   

Department: MSAT team
Reports To: Director, Validation
 

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 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 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.

One of the focuses of this job is to support manufacturing and laboratory equipment, systems, facilities, and utilities commissioning, qualification and validation activities required for clinical and commercial biologics manufacturing as part of a fast-paced and collaborative global validation team.  These responsibilities span all phases of the lifecycle from system implementation and qualification to cleaning and shipping validation. 

What You’ll Do:

• Support the generation of key deliverables in a phase appropriate compliance manner as part of global CQV strategy for F&U, Equipment, QC/Analytical, Cleaning and Shipping 

• Support development of robust collaboration for CSV and Process Validations 

• Support development and deployment of periodic review strategy for systems 

• Generate, execute, review, and approval commissioning and qualification protocols for new manufacturing equipment, systems, facilities, and utilities 

• Generate, review and approval of requirements traceability matrices and qualification summary reports for new equipment and systems 

• Support validation deviation resolution including troubleshooting and root cause analysis 

• Support the development of the qualification and validation programs at Just including the transition from paper based to digital validation software to configure globally scalable end to end paperless solutions to manage the validation lifecycle 

• Develop compliant and novel ways to comply with regulatory requirements 

• Support inspection readiness activities, Health Authority and Client audits, and support corrective actions based on audit findings 

• Support CQV activities across global expansion sites 

Who You Are:

• Bachelor’s degree in engineering science or related program with the following years in relevant experience: 

• For Val Engineer II - 3+ years 

• Understanding of industry standards and best practices for a science and risk-based approach to qualification of systems, equipment, utilities, and/or facilities 

• Working knowledge of US FDA CFRs and European EMA, including ICH regulations 

• Experience with quality risk management 

• Experience authoring, reviewing, and approving validation documentation 

• Knowledge of process equipment, utilities, operations, and engineering principles 

• Must possess problem-solving and critical thinking skills 

• Ability to work both independently and collaboratively across multiple disciplines in a fast-paced and dynamic environment 

• High level oral and written communication skills are a must 

Additional Qualifications: 

• Understanding of process automation (e.g. DeltaV) 

• Previous work experience with Complex Equipment, Distributed Control System (DCS), Building Automation Systems (BAS), PLC, SCADA, PI, and MES will be a plus 

• Applies knowledge and expertise to solve complex technical problems 

• Significant contributor to multi-disciplinary teams at the functional level 

• Working knowledge of the following: Utilities and facilities and computerized system, analytical equipment and systems and shipping and transport logistics, cleaning validation methodologies and process validation  

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 work options to help you balance your professional and personal life, whether that means working remotely or choosing a hybrid model.

• Inclusive Culture: We’re committed to building a diverse and inclusive environment where everyone’s voice is valued, and curiosity is encouraged.

• Innovative Projects: You’ll 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 don’t just talk about thinking outside the box—we throw the box away. If you’ve got ideas, we want to hear them.

Are You Still Curious?

If you’ve read this far, then chances are you’ve got a curious mind—just like us. So, what are you waiting for? Take the leap and apply today. We can’t wait to see where your curiosity leads you—and 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 $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.