Validation (CQV) Engineer
On-siteCollege Station, Texas, United States
Job Summary
Execute full validation lifecycle activities including Cycle Development, Commissioning & Qualification, Performance Qualification, and Periodic Reviews for product launches and technology transfers. Create and manage detailed project plans for IQ/OQ/PQ execution while independently troubleshooting technical issues and resolving vendor deviations. Lead cross-functional teams to coordinate complex projects, ensuring right-first-time execution and compliance across all validation documentation. This on-site role requires availability for holidays and weekends and supports implementation of new process technologies aligned with regulatory needs.
Required Qualifications
- On-site role; remote work is not permitted
- Experience creating full validation lifecycle documentation: URS, FRS, DS, engineering specifications
- Validation protocols (VPP, IQ, OQ, PQ)
- System Impact Assessments, Requirements Traceability Matrix, Final Reports
- Strong understanding of validation processes and regulatory requirements
- Ability to independently troubleshoot, resolve, and communicate technical issues
- Proven experience leading cross-functional teams and coordinating complex projects
- Ability to develop and manage detailed project plans and timelines for IQ/OQ/PQ/RQP execution
- Working knowledge of Computerized Systems Validation (CSV)
- Support implementation of new process technologies aligned with business and regulatory needs
- Review and approval of vendor protocols
- Issue resolution
- Validation deviation reporting
- Summary report generation
- Sample collection
- Data retrieval
- Documentation completion per protocol requirements
- Excellent technical writing skills for SOP creation and updates
- Proficiency in Microsoft Word, Excel, and PowerPoint
- Ability to work independently, multitask, and support multiple projects simultaneously
- Provide guidance and support to junior team members
- Must be available to work as needed, including holidays and weekends
- Bachelor's degree in Engineering or Science (minimum)
- 7+ years of validation experience in the life sciences industry
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