Senior Validation Engineer
Job Summary
Supporting the computer system validation process, the full-time Senior Validation Engineer will lead the gathering of business requirements, conduct validation testing, and ensure compliance with industry standards while working remotely.
Key responsibilities
- Lead the preparation, execution, and analysis of Validation Protocols and related documentation
- Conduct risk assessments and provide technical decision-making for validation strategies on complex projects
- Collaborate with cross-functional teams to ensure alignment with system requirements and regulatory compliance
Required qualifications
- Bachelor's degree in Computer Science, Engineering, or a related discipline, plus five years of relevant experience; or a Master's degree with three years of experience
- Experience with Electronic Document Management Systems and validation protocols in the pharmaceutical healthcare industry
- Knowledge of FDA 21 CFR part 11 and GxP compliance
- Proficiency in writing SQL queries and utilizing Microsoft relational databases
- Experience with test documentation and defect tracking in systems like HP Quality Center and Team Foundation Server
Complete Job Description
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