Dotmatics

Lead Validation Engineer

Dotmatics

full-time

Posted on:

Location Type: Remote

Location: United Kingdom

Visit company website

Explore more

✨ AI Apply
Apply

Job Level

Senior

Tech Stack

CloudCypressSDLC

About the role

  • Lead validation activities for the Dotmatics Luma platform and its internal systems operating under GxP requirements
  • Serve as the subject matter expert for computer system validation (CSV)
  • Ensure that software development, testing, and release activities comply with applicable regulations and standards
  • Partner closely with Product, Engineering, and Quality Management teams to drive validation best practices throughout the software development lifecycle (SDLC)
  • Author, review, and approve validation lifecycle documentation including Validation Master Plans, URS, FRS, Traceability Matrix, Risk Assessments, IQ, OQ, PQ protocols and reports
  • 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.
  • Mentor/lead junior validation team members and QA staff on validation methodologies and documentation best practices.
  • 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.

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
  • Bachelor’s degree in Computer Science, Biology, Chemistry, Engineering, or a related field (preferred but not required).
  • Background in regulated life sciences environments, such as pharmaceutical, biotech, or medical device industries.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
computer system validation (CSV)validation lifecycle documentationIQ protocolsOQ protocolsPQ protocolsrisk assessmentstraceability matricesautomated testing toolsGAMP 5ISO 9001
Soft Skills
mentoringleadershipcommunicationcollaborationtraining