Senior Computer System Validation Specialist
Job Summary
Leading risk-based validation and assurance activities for GxP-regulated computerized systems, the full-time Senior Computer System Validation Specialist will provide technical leadership in validation strategy and execution, ensuring compliance and quality while mentoring junior team members in a remote setting.
Key responsibilities
- Lead planning, execution, review, and approval of validation and assurance deliverables for GxP systems and changes
- Author, review, or approve validation lifecycle deliverables, ensuring documentation is complete and inspection-ready
- Provide IT Quality and Compliance oversight, supporting audits and identifying compliance gaps and process improvement opportunities
Required qualifications
- Bachelor's degree in Computer Science, Information Systems, Engineering, Life Sciences, Quality, or a related field, or equivalent experience
- 5+ years of experience in CSV, CSA, IT quality, software validation, change control, SDLC, or GxP computerized systems
- Strong knowledge of computerized system validation, GAMP 5, SDLC, and regulatory requirements
- Experience leading validation strategy and deliverable execution for various systems
- Ability to mentor and provide technical guidance to less senior validation or quality resources
Complete Job Description
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