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Lead Validation Engineer

EngineerEngineerFull TimeRemoteSeniorTeam 501-1,000H1B SponsorCompany SiteLinkedIn

Location

United Kingdom

Posted

31 days ago

Salary

£69.1K - £93.4K / year

Seniority

Senior

Bachelor Degree3 yrs expEnglishCloudCypressSDLC

Job Description

Lead Validation Engineer

Dotmatics

• Author, review, and approve validation lifecycle documentation including Validation Master Plans, URS, FRS, Traceability Matrix, Risk Assessments, IQ, OQ, PQ protocols and reports following GAMP 5 principles, including risk-based approaches to validation activities • Working with the software quality team and devops to leverage automated tools such as Cypress to develop, review and run IQ, OQ, and PQ protocols. • Apply GAMP 5 framework to determine appropriate validation strategies and documentation requirements. • Mentor/lead junior validation team members and QA staff on validation methodologies and documentation best practices. • Coordinate and execute validation testing activities, manage defect identification, impact assessment, and resolution. • Serve as Luma subject matter expert for GAMP5, 21 CFR Part, EU Annex 11, and applicable ISO standards. • Provide validation guidance and training to engineers, QA analysts, and project managers on CSV principles, IQ/OQ/PQ expectations, and 21 CFR Part 11 controls.

Job Requirements

  • Deep working knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and GxP requirements as they apply to software systems
  • Familiarity with ISO 9001 quality management system principles
  • Demonstrated experience authoring and executing IQ/OQ/PQ protocols, traceability matrices, and validation summary reports, including use of automated testing tools (e.g., Cypress, Playwright) to generate and capture test evidence
  • Understanding of software development lifecycle (SDLC) and Agile methodologies.
  • Experience with validation of cloud-based systems, SaaS applications, or commercial off-the-shelf (COTS) software.

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