Lead Validation Engineer

Dotmatics

. Lead validation activities for the Dotmatics Luma platform and internal systems operating under GxP requirements .

Posted 10/27/2026full-timeRemote • United Kingdom, IrelandSenior💰 £69,062 - £93,436 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in computer system validation (CSV) and GxP compliance, with a strong focus on authoring and executing validation documentation and protocols. Proven ability to mentor teams and collaborate effectively in regulated life sciences environments.

Highest-signal resume keywords

Computer System Validation (CSV)GxP ComplianceGAMP 5Automated Testing Tools (Cypress, Playwright)Validation Documentation (IQ/OQ/PQ)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Validation Master PlansUser Requirement Specifications (URS)Functional Requirement Specifications (FRS)Traceability MatrixRisk AssessmentsInstallation Qualification (IQ)Operational Qualification (OQ)Performance Qualification (PQ)Software Development Lifecycle (SDLC)Agile Methodologies

Soft Skills

MentoringCollaborationTraining

Tools & Technologies

CypressPlaywright

Industry Keywords

21 CFR Part 11EU Annex 11ISO 9001Cloud-Based SystemsSaaS ApplicationsCommercial Off-The-Shelf (COTS)Regulated Life SciencesPharmaceuticalBiotechMedical Device

Tech Stack

Tools & technologies

CloudCypressSDLC

About the role

Key responsibilities & impact

Lead validation activities for the Dotmatics Luma platform and internal systems operating under GxP requirements
Serve as the subject matter expert for computer system validation (CSV)
Ensure software development, testing, and release activities comply with applicable regulations and standards
Author, review, and approve validation lifecycle documentation, including Validation Master Plans, URS, FRS, Traceability Matrix, Risk Assessments, IQ, OQ, and PQ protocols and reports
Work with software quality and DevOps teams to leverage automated tools such as Cypress for IQ, OQ, and PQ protocols
Apply GAMP 5 to determine validation strategies and documentation requirements
Mentor and lead junior validation team members and QA staff
Provide validation guidance and training to engineers, QA analysts, and project managers
Support customer-facing validation activities
Coordinate validation testing and defect resolution
Assist with CAPA investigations and audit responses
Collaborate with Quality Management on document control, periodic reviews, and audit readiness

Requirements

What you’ll need

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
Experience using automated testing tools such as Cypress or Playwright to generate and capture test evidence
Understanding of software development lifecycle (SDLC) and Agile methodologies
Experience validating 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

Benefits

Comp & perks

Dynamic, remote-friendly environment
Collaborative global team
Equal opportunity workplace
Supportive and connected work environment