Senior Process Validation Engineer
Evotec
Validation Engineer II
Evotec
full-time
Posted on:
Location Type: Office
Location: Redmond • Washington • 🇺🇸 United States
Visit company websiteSalary
💰 $79,800 - $109,250 per year
Job Level
JuniorMid-Level
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 with 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
- Proven knowledge of cGMP requirements and experience writing manufacturing technical documents
- Experience leading technical projects and managing timelines with external collaborators and vendors
Benefits
- discretionary annual bonus
- comprehensive benefits to include Medical, Dental and Vision
- short-term and long-term disability
- company paid basic life insurance
- 401k company match
- flexible work
- generous paid time off and 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
FUSE commissioningvalidation activitiesvalidation lifecycle documentsvalidation protocolsrisk assessmentstroubleshootingroot cause analysisquality risk managementcGMP requirementsmanufacturing technical documents
Soft skills
problem-solvingcritical thinkinginterpersonal skillsteam collaborationself-startermechanical aptitudeleadershipproject managementcommunication skillsmotivated