Job Summary
Position: Computer System Validation Engineer
Location : Bothell WA
Duration :12 months
Pay range : $70- 79/hr on W2
We are seeking a CSV / Validation Engineer to support validation activities for GxP computerized systems in a GMP manufacturing environment. The role focuses on ensuring compliance of Manufacturing Execution Systems (MES), ERP systems, and other regulated applications throughout the system lifecycle.
The ideal candidate will work closely with Business Owners, Technical Owners, and Quality teams to deliver and maintain validation documentation in alignment with regulatory requirements and internal procedures.
Key Responsibilities
- Author, review, and approve Computer System Validation (CSV) documentation
- Support test execution activities (IQ/OQ/PQ), including documenting test results and deviations
- Collaborate with Business and Technical Owners to define system requirements and specifications for GxP systems
- Ensure validation activities comply with GMP, SOPs, and regulatory expectations
- Maintain traceability matrices, validation plans, test scripts, and summary reports
- Support validation lifecycle activities for MES, ERP, and EBR systems
- Ensure all deliverables are inspection/audit ready
Must-Have Qualifications
- Experience in a GMP manufacturing environment
- Strong understanding of Good Manufacturing Practices (GMP) and SOP adherence
- Experience working with GxP regulated systems
- Knowledge of Computer System Validation (CSV) principles
- Ability to work in a structured, regulated production environment (including cleanroom compliance if applicable)
Nice-to-Have Qualifications
- Experience with MES systems (e.g., Emerson Syncade)
- Experience with ERP systems (SAP or Oracle)
- Exposure to Electronic Batch Records (EBR) systems (e.g., InfoBatch)
- Experience with Veeva or ServiceNow platforms
Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals. Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit https://dexian.com/ to learn more. Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status
Pay: $70.00 - $79.00 per hour
Work Location: Hybrid remote in Bothell, WA 98011
