Mani G. Email
Senior Validation Engineer - IOPS QA @ Regeneron
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Mani G. Location
- Boston, MA, US
Mani G. Work
- 2025 -now Senior Validation Engineer - IOPS QA @
- 2025 -2025 Validation Lead (CSV) @
- 2023 -2025 Senior Software Quality Assurance Engineer @
- 2022 -2023 Digital CSV Lead @
- 2020 -2022 Lead Systems Engineer @
- 2019 -2020 Validation QA Engineer @
- 2018 -2018 Validation Engineer- EMU @
- 2018 -2018 Validation Engineer- Remediation @
- 2016 -2018 Validation Engineer- Quality Engineering @ Renaissance Lakewood, LLC
Mani G. Education
- Stanford University
(Connecting Data Analytics with Managerial Success (BUS 36))
- University of Minnesota
Specialization (Software Development Life Cycle (SDLC); Software Testing and Automation)
- Silicon Valley University
Master's degree (Computer Science)
- Northwestern Polytechnic University
Bachelor's degree (Computer Science)
Mani G. Skills
- Computer System Validation
- Computer Software Assurance - CSA
- Program Management
- Regulatory Compliance
- Microsoft Outlook
- Technical Writer
- Document Management
- Verification and Validation (V&V)
- Cross-functional Team Leadership
- Test Planning
- GAMP
- Analytical Skills
- Project Management
- U.S. Title 21 CFR Part 11 Regulation
- Business Process Improvement
- Manual Testing
- Automation testing
- Jama Connect
- 21 CFR Part 11 | 21 CFR Part 58 | 21 CFR Part 210 | 21 CFR Part 211 | 21 CFR Part 820
- ISO 13485 | ISO 14971| ISO/IEC 27001 | ICE 62304 | GAMP 5 | MDSAP | SaMD | GXP
- EU Annex 11 | cGxP | GMP | GDP | GLP | GCP | ALCOA | ISPE
- Teams | Outlook | Word | Excel | PPT | Visio | Planner | SharePoint | G Suite | Microsoft 365
- TFS- Team Foundation Server | Miro | Trello | Azure DevOps | Smartsheet | Confluence
- Slack | Asana | Box | One Drive| Zoom | Salesforce |ServiceNow
- SDLC | Waterfall Model | V - Model | Agile Model | Scaled Agile Framework® (SAFe®)
- Computer Software Assurance for Production and Quality System Software
- Corrective and Preventive Action (CAPA)
- Quality System
- Regulatory Affairs
- Good Laboratory Practice (GLP)
- Testing
- GxP
- Management
- Learning Management Systems
- Change Management
Mani G. Summary
- Mani G., based in Boston, MA, US, is currently a Senior Validation Engineer - IOPS QA at Regeneron. Mani G. brings experience from previous roles at GSK, Guardant Health, Resilience and Roche. Mani G. holds a Stanford University. With a robust skill set that includes Computer System Validation, Computer Software Assurance - CSA, Program Management, Regulatory Compliance, Microsoft Outlook and more. Mani G. has 1 emails on RocketReach.
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