Validation Engineer III
Evotec
August 08, 2026
On-site
Redmond, WA
Operations
What You’ll Do
- Lead the generation of 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 validation master plans.
- Liaise with equipment, operations, logistics, QC, tech transfer, process development teams, and third-party contractors to define and perform cycle development, qualification, and validation activities.
- Author validation documentation (risk/gap assessments, cycle development protocols/reports/procedures, qualification/validation protocols and reports, validation discrepancies).
- Lead validation discrepancy resolution via troubleshooting and root cause analysis.
- Support development of qualification/validation programs, including transition from paper-based to digital validation software for scalable, end-to-end paperless validation lifecycle.
- Develop and strategize compliant/novel ways to meet regulatory requirements.
- Support inspection readiness, Health Authority and Client audits, and corrective actions.
- Lead CQV activities across global expansion sites.
Who You Are
- Bachelor’s degree in engineering science or related field; 7+ years relevant experience (Validation Engineer III).
- Science- and risk-based qualification approach; industry standards and best practices.
- Working knowledge of US FDA CFRs and European EMA, including ICH regulations.
- Quality risk management experience.
- 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; ability to work independently and cross-functionally in fast-paced environments.
- Excellent interpersonal, team, and communication skills; strong oral/written communication; strong task/time management.
Additional Qualifications
- Experience applying expertise to solve complex technical problems; contributor to multi-disciplinary teams; led teams or large validation projects.
- Working knowledge of shipping/cleaning, process validation, utilities/facilities, computerized systems, analytical equipment/systems.
Application instructions
- Apply today.
- Lead the generation of 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 validation master plans.
- Liaise with equipment, operations, logistics, QC, tech transfer, process development teams, and third-party contractors to define and perform cycle development, qualification, and validation activities.
- Author validation documentation (risk/gap assessments, cycle development protocols/reports/procedures, qualification/validation protocols and reports, validation discrepancies).
- Lead validation discrepancy resolution via troubleshooting and root cause analysis.
- Support development of qualification/validation programs, including transition from paper-based to digital validation software for scalable, end-to-end paperless validation lifecycle.
- Develop and strategize compliant/novel ways to meet regulatory requirements.
- Support inspection readiness, Health Authority and Client audits, and corrective actions.
- Lead CQV activities across global expansion sites.
Who You Are
- Bachelor’s degree in engineering science or related field; 7+ years relevant experience (Validation Engineer III).
- Science- and risk-based qualification approach; industry standards and best practices.
- Working knowledge of US FDA CFRs and European EMA, including ICH regulations.
- Quality risk management experience.
- 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; ability to work independently and cross-functionally in fast-paced environments.
- Excellent interpersonal, team, and communication skills; strong oral/written communication; strong task/time management.
Additional Qualifications
- Experience applying expertise to solve complex technical problems; contributor to multi-disciplinary teams; led teams or large validation projects.
- Working knowledge of shipping/cleaning, process validation, utilities/facilities, computerized systems, analytical equipment/systems.
Application instructions
- Apply today.