Validation Engineer III, Cleaning & Shipping

Job Title

Validation Engineer III, Cleaning & Shipping

Redmond, WA

Director, Validation

At Just-Evotec, 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!

We’re looking for a passionate and curious Validation Engineer III 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 III, you’ll play a key role in developing and executing validation strategies supporting late-phase and commercial biologics manufacturing, with a primary focus on cleaning validation.

As part of our collaborative global Validation team, you’ll partner across Operations, Logistics, Quality, Tech Transfer, Process Development, Engineering, and external vendors to develop and execute compliant, science- and risk-based validation programs. You’ll have the opportunity to take ownership of complex validation activities, lead investigations and problem-solving efforts, and contribute to validation strategies that support our growing biologics manufacturing network.

The role may also support commissioning, qualification, and validation activities for manufacturing and laboratory equipment, facilities, utilities, and systems as business needs require.

• Lead the development and execution of phase-appropriate validation deliverables supporting global CQV strategies, with a focus on cleaning and shipping validation.
• Develop validation strategies and programs, including Validation Master Plans (VMPs) and supporting documentation.
• Liaise with the equipment, operations, logistics, qc, tech transfer, process development teams and third-party contractors, as applicable, to define and identify and perform cycle development, qualification and validation activities.
• Author validation documentation including, but not limited to, risk and gap assessments, cycle development protocols / reports / procedures, qualification/validation protocols and reports, and validation discrepancies.
• Lead validation discrepancy resolution, including troubleshooting, root cause analysis, and development of appropriate corrective actions.
• 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 and strategize 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.
• Lead CQV activities across global expansion sites.

Bachelor’s degree in engineering science or related program with the following years in relevant experience: 7+ years

• Strong technical expertise in cleaning validation within a GMP pharmaceutical or biologics manufacturing environment.
• Understanding of industry standards and best practices for a science and risk-based approach to qualification of systems and processes
• Working knowledge of US FDA CFRs and European EMA, including ICH regulations
• Experience with quality risk management
• Experience authoring, reviewing,…