Senior Validation Engineer – Cleaning & Shipping

Evote; Union Hill-Novelty Hill (WA); On-site; USD 115,000 - 127,000; Full time

Benefits offered by this job

Growth opportunities

Inclusive culture

Innovative projects

Big ideas

Job summary

Evotec in Redmond, WA is seeking a Validation Engineer III focused on Cleaning, Shipping and process validation for late-stage and commercial biologics. You will drive CQV activities, develop validation master plans, and collaborate with cross-functional teams to ensure compliant, timely deliveries.

The role requires 7+ years in the field, a engineering degree, and strong regulatory knowledge. You will help transition to digital validation tools and support inspections and audits.

Qualifications

• Bachelor’s degree in engineering with 7+ years in validation or CQV.
• Expert knowledge of shipping and cleaning processes.
• Proficient in US FDA CFRs, EMA and ICH regulations.
• Experience authoring validation documents and risk assessments.
• Ability to lead cross-functional teams across sites.

Responsibilities

• Lead generation of key deliverables in global CQV strategy for F/U, Equipment, QC/Analytical, Cleaning and Shipping.
• Draft validation master plans and program strategies.
• Coordinate with equipment, operations, logistics, QC, tech transfer and contractors for cycle development, qualification and validation.
• Author validation documentation including risk assessments, protocols, reports, and validation discrepancies.
• Lead validation discrepancy resolution including root cause analysis.
• Support digital validation software adoption to enable paperless global lifecycle management.
• Develop compliant and novel approaches to meet regulatory requirements.
• Support inspection readiness, audits, and corrective actions.
• Lead CQV activities across global expansion sites.

Skills

Shipping & Cleaning expertise

Regulatory knowledge (FDA CFRs, EMA/IC

Quality risk management

Validation documentation skills

Cross-functional collaboration

Problem-solving & critical thinking

Strong communication skills

Education

Bachelor’s degree in Engineering or related field

Job description

Evotec in Redmond, WA is seeking a Validation Engineer III focused on Cleaning, Shipping and process validation for late-stage and commercial biologics. You will drive CQV activities, develop validation master plans, and collaborate with cross-functional teams to ensure compliant, timely deliveries.

The role requires 7+ years in the field, a engineering degree, and strong regulatory knowledge. You will help transition to digital validation tools and support inspections and audits.