Validation Engineer II
Evotec
full-time
Posted on:
Location Type: Office
Location: Redmond • Washington • United States
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Salary
💰 $79,800 - $109,250 per year
About the role
- Execute FUSE commissioning and validation activities for early stage clinical manufacturing, late-stage molecule/ commercial manufacturing and/or PPQ campaign support.
- Generate and review technical documentation including validation lifecycle documents, validation protocols and associated reports related to the equipment validation lifecycle.
- In collaboration with cross functional teams, develop Validation Master Plans, provide process knowledge to support the validation execution and risk assessments.
- Lead the development and implementation of templates and validation workflows.
- Support the generation of governance policies and related SOPs for commissioning of FUSE.
- Support validation deviation resolution including troubleshooting and root cause analysis
- Support the periodic review of qualified/validated FUSE across JUST WA sites.
- Support inspection readiness activities, Health Authority and Client audits, and support corrective actions based on audit findings
Requirements
- Bachelor’s degree in engineering science or related program
- Minimum 2 years relevant experience
- Proven experience in executing commissioning and validation activities of FUSE
- Understanding of GMP concepts and Quality systems necessary to execute validation activities
- Understanding of industry standards and best practices for a science and risk-based approach to qualification of systems, equipment, utilities, and/or facilities
- Knowledge of process equipment, utilities, operations, and engineering principles
- Experience in quality risk management
- Must possess problem-solving and critical thinking skills
- Good interpersonal, team, and collaborative skills
- Motivated, self-starter with strong mechanical aptitude
- Experience leading technical projects and managing timelines with external collaborators and vendors
Benefits
- Health insurance
- 401k company match
- Flexible work
- Generous paid time off
- Paid holiday
- Wellness and transportation benefits
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
FUSE commissioningvalidation activitiesvalidation lifecycle documentsvalidation protocolsrisk assessmentstroubleshootingroot cause analysisquality risk managementengineering principlesGMP concepts
Soft Skills
problem-solvingcritical thinkinginterpersonal skillsteam collaborationself-startermechanical aptitudeleadershipproject managementcommunication skillsmotivated
Certifications
Bachelor’s degree in engineering science