Validation Engineer III

Job Title

Validation Engineer III

Redmond, WA

We’re looking for a passionate and curious Validation Engineer III to join our team. In this role you will strategize, implement, and support cleaning, shipping, and process validation activities for late‑phase and commercial biologics manufacturing within a fast‑paced, global validation team. You will also support the commissioning, qualification, and validation of manufacturing equipment, systems, facilities, and utilities as required.

• Lead 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.
• Document a strategy for validation programs, including generation of validation master plans.
• Liaise with equipment, operations, logistics, QC, tech transfer, process development teams, and third‑party contractors to define, identify, and perform cycle development, qualification, and validation activities.
• Author validation documentation such as risk and gap assessments, cycle development protocols, qualification/validation protocols, discrepancy reports, and root‑cause analyses.
• Lead validation discrepancy resolution, including troubleshooting and root‑cause analysis.
• Support the transition from paper‑based to digital validation software, configuring globally scalable, end‑to‑end paperless solutions.
• Develop and strategize compliance methods for regulatory requirements and support inspection readiness activities, health authority and client audits, and corrective actions based on audit findings.
• Lead CQV activities across global expansion sites.

• Bachelor’s degree in engineering science or a related program.
• 7+ years of relevant experience as a Validation Engineer III.
• 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, European EMA, and ICH regulations.
• Experience with quality risk management.
• Experience authoring, reviewing, and approving validation documentation.
• Knowledge of process equipment, utilities, operations, and engineering principles.
• Strong focus on quality, attention to detail, and problem‑solving skills.
• Self‑starter with strong mechanical aptitude and the ability to work independently and collaboratively in a fast‑paced environment.
• Excellent interpersonal, team, and communication skills with high‑level oral and written communication abilities.
• Effective task/time management and organizational skills.

• Applied knowledge and expertise to solve complex technical problems.
• Significant contributor in multi‑disciplinary functional teams.
• Led a team or large validation projects.
• Working knowledge of shipping and cleaning.
• Working knowledge of process validation.
• Working knowledge of utilities and facilities.
• Working knowledge of computerized systems.
• Working knowledge of analytical equipment and systems.

The base pay range for this position at commencement of employment is expected to be $115,000 to $126,500. Base salary may vary depending on skills, experience, and market value. Additional rewards include discretionary annual bonus, comprehensive benefits (medical, dental, vision, short‑term and long‑term disability, life insurance), 401(k) company match, flexible work, paid time off, paid holidays, 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.