Validation Lead Software Engineer

Neogenomics Laboratories Aliso Viejo , CA 92698

Posted 1 week ago

Consultant: Validation Lead Software Engineer

Duration 3 to 6 months before conversion to full time

Minimum Experience requirement:

  • 8+ years of experience is needed working in QA and Validation environments

  • Must be having minimum 3-4 years of experience working with offshore teams

  • Hands-on Experience in 21 CFR Validation Solutions, Framework and SOP Development, Development and Execution of Validation Strategy.

  • Must be having a proven experience in:

  • Validation Planning, Risk Assessment, Effort Estimation, Deviation Management, FDA 21 CFR Part 11 Process

  • Validation Deliverables such as Risk Assessment, Qualification Protocols, Traceability Matrix, Validation Execution Evidence and Validation Summary Reports.

  • Agile and waterfall Testing Methodologies

  • Centralized Validation Management

  • Defect/Deviation Management and Triaging

  • Testing/Validation Retrospection Management

  • Test Co-ordination in Distributed Agile Methodology

  • Backend Database Testing

  • Risk Based Testing Methodology

  • Healthcare Regulatory and Compliance Testing

  • Must be able to perform validation tasks in all phases of Software Development Lifecycle (SDLC)

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Validation Lead Software Engineer

Neogenomics Laboratories