Validation Engineer III
Evotec
June 25, 2026
On-site
Redmond, WA
IT
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
- 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 (troubleshooting and root cause analysis)
- Support development of qualification/validation programs, including transitioning from paper-based to digital validation software and scalable end-to-end paperless solutions
- Develop and strategize compliant and novel ways to meet regulatory requirements
- Support inspection readiness, Health Authority/Client audits, and corrective actions
- Lead CQV activities across global expansion sites
Who You Are
- Bachelor’s degree in engineering science or related program; Validation Engineer III: 7+ years relevant experience
- Science- and risk-based qualification approach; industry standards and best practices
- Working knowledge of US FDA CFRs and European EMA, including 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 and attention to detail
- Problem-solving/critical thinking; self-starter with mechanical aptitude
- Ability to work independently and collaboratively across disciplines; strong interpersonal and communication skills; strong task/time management
Additional Qualifications
- Applies expertise to solve complex technical problems; significant contributor to multidisciplinary teams; led teams/large validation projects
- Working knowledge of shipping/cleaning, process validation, utilities/facilities, computerized systems, analytical equipment/systems
Application Instructions
- 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
- 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 (troubleshooting and root cause analysis)
- Support development of qualification/validation programs, including transitioning from paper-based to digital validation software and scalable end-to-end paperless solutions
- Develop and strategize compliant and novel ways to meet regulatory requirements
- Support inspection readiness, Health Authority/Client audits, and corrective actions
- Lead CQV activities across global expansion sites
Who You Are
- Bachelor’s degree in engineering science or related program; Validation Engineer III: 7+ years relevant experience
- Science- and risk-based qualification approach; industry standards and best practices
- Working knowledge of US FDA CFRs and European EMA, including 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 and attention to detail
- Problem-solving/critical thinking; self-starter with mechanical aptitude
- Ability to work independently and collaboratively across disciplines; strong interpersonal and communication skills; strong task/time management
Additional Qualifications
- Applies expertise to solve complex technical problems; significant contributor to multidisciplinary teams; led teams/large validation projects
- Working knowledge of shipping/cleaning, process validation, utilities/facilities, computerized systems, analytical equipment/systems
Application Instructions
- Take the leap and apply today.