6424 - Lead Validation Engineer (Data Lake) / CSV Engineer
Tasks
- Assess data lake architecture and validation deliverables
- Author and maintain validation plans and specifications
- Develop IQ protocols and OQ protocols
- Develop data lake administration SOPs
- Develop scalable qualification model for GxP systems
- Ensure alignment with 21 CFR Part 11 and EU GMP Annex 11
- Ensure compliance with GAMP 5 and CSA guidance
- Establish validation governance and procedures
- Execute and coordinate testing activities
- Implement risk based verification approaches
- Lead validation qualification activities
- Manage validation lifecycle and change control
- Perform supplier assessments and risk based verification
- Support Power BI solutions for GxP processes
Perks/Benefits
- 401k employer match
- Commuter benefits
- Employee recognition
- Employee referral program
- Health savings account
- Medical/Dental/Vision insurance
- Paid parental leave
- Paid time off
- Tuition reimbursement
Skills/Tech-stack
21 CFR | 21 CFR Part 11 | Annex 11 | Azure Data | Azure Data Factory | Azure Data Lake | Azure Data Lake Storage | CFR Part 11 | Change Control | Cloud validation | Computer Software | Computer Software Assurance | Computer system | Computer system validation | Data Engineering | Data Factory | Data Governance | Data Integrity | Data Lake Storage | Databricks | Documentation Practices | EU GMP | EU GMP Annex 11 | GAMP 5 | GAMP 5 Second Edition | GMP Annex 11 | Good documentation | Good documentation practices | Infrastructure qualification | Microsoft Azure | Microsoft Fabric | Operational Qualification | PaaS Validation | Part 11 | Power BI | Risk Based Verification | Risk-based | SDLC | SaaS validation | Software Assurance | System validation | Test Documentation | Test Execution
Roles
Engineer | Lead | Lead Validation Engineer | Validation Engineer
Regions
Countries
States
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