Validation Engineer III
Evotec
August 29, 2026
On-site
Redmond, WA
Operations
What You’ll Do
- Lead key deliverables in a phase-appropriate compliance manner as part of global CQV strategy for Facilities & Utilities, Equipment, QC/Analytical, Cleaning and Shipping.
- Document validation program strategy, including generation of validation master plans.
- Coordinate with equipment, operations, logistics, QC, tech transfer, process development, and third parties to define and perform cycle development, qualification, and validation activities.
- Author validation documentation (risk/gap assessments, protocols/reports/procedures, qualification/validation protocols and reports, and validation discrepancies).
- Lead validation discrepancy resolution, including troubleshooting and root-cause analysis.
- Support development of qualification/validation programs, including transition from paper-based to digital validation software for globally scalable paperless solutions.
- Develop compliant and novel approaches to meet regulatory requirements.
- Support inspection readiness, Health Authority/Client audits, and corrective actions.
- Lead CQV activities across global expansion sites.
Who You Are / Qualifications
- Bachelor’s degree in engineering science or related program; 7+ years relevant validation experience.
- Knowledge of industry standards and best practices for science- and risk-based qualification.
- Working knowledge of US FDA CFRs, European EMA, and ICH regulations.
- Experience with quality risk management.
- Experience authoring/reviewing/approving validation documentation.
- Knowledge of process equipment, utilities, operations, and engineering principles.
- Strong quality focus, attention to detail, problem-solving/critical thinking.
- Self-starter with strong mechanical aptitude; works independently and collaboratively across disciplines.
- Excellent interpersonal, communication (oral/written), and task/time-management skills.
Application
- Take the leap and apply today.
- Lead key deliverables in a phase-appropriate compliance manner as part of global CQV strategy for Facilities & Utilities, Equipment, QC/Analytical, Cleaning and Shipping.
- Document validation program strategy, including generation of validation master plans.
- Coordinate with equipment, operations, logistics, QC, tech transfer, process development, and third parties to define and perform cycle development, qualification, and validation activities.
- Author validation documentation (risk/gap assessments, protocols/reports/procedures, qualification/validation protocols and reports, and validation discrepancies).
- Lead validation discrepancy resolution, including troubleshooting and root-cause analysis.
- Support development of qualification/validation programs, including transition from paper-based to digital validation software for globally scalable paperless solutions.
- Develop compliant and novel approaches to meet regulatory requirements.
- Support inspection readiness, Health Authority/Client audits, and corrective actions.
- Lead CQV activities across global expansion sites.
Who You Are / Qualifications
- Bachelor’s degree in engineering science or related program; 7+ years relevant validation experience.
- Knowledge of industry standards and best practices for science- and risk-based qualification.
- Working knowledge of US FDA CFRs, European EMA, and ICH regulations.
- Experience with quality risk management.
- Experience authoring/reviewing/approving validation documentation.
- Knowledge of process equipment, utilities, operations, and engineering principles.
- Strong quality focus, attention to detail, problem-solving/critical thinking.
- Self-starter with strong mechanical aptitude; works independently and collaboratively across disciplines.
- Excellent interpersonal, communication (oral/written), and task/time-management skills.
Application
- Take the leap and apply today.