Validation Engineer III

Evotec WD; Redmond (WA); On-site; USD 115,000 - 126,500; Full time

Benefits offered by this job

Discretionary annual bonus

Comprehensive benefits

401(k) company match

Flexible work

Paid time off

Wellness benefits

Job summary

Evotec WD in Redmond, WA is hiring a Validation Engineer III to join their global validation team. This role involves strategizing and supporting validation activities for biologics manufacturing.

The ideal candidate will lead validation documentation processes, collaborate across teams, and ensure compliance with regulatory standards. A Bachelor's degree in engineering and 7+ years of experience in validation are required, emphasizing problem-solving skills and attention to detail. Excellent benefits and a focus on wellness are part of the offer.

Qualifications

• 7+ years of relevant experience as a Validation Engineer III.
• Understanding of industry standards for qualification of systems and processes.
• Strong focus on quality and problem-solving skills.

Responsibilities

• Lead the generation of key deliverables for validation programs.
• Document a strategy for validation programs.
• Liaise with teams to perform qualification and validation activities.

Skills

Problem-solving skills

Attention to detail

Interpersonal skills

Team collaboration

Mechanical aptitude

Education

Bachelor’s degree in engineering science or related program

Tools

Quality risk management techniques

Validation documentation

CFRs and ICH regulations knowledge

Job description

Job Title

Validation Engineer III

Location

Redmond, WA

The Role

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.

What You’ll Do

• 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.

Who You Are

• 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.

Additional Qualifications

• 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.

Compensation

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.

Equal Opportunity Employer

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.