Lead Validation Engineer

Dotmatics

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

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

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in computer system validation (CSV) and GxP compliance, with a strong focus on authoring validation documentation and executing validation protocols. Proficient in utilizing automated testing tools and collaborating with cross-functional teams to ensure software quality and regulatory adherence.

Highest-signal resume keywords

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

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

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

Hard Skills

Validation Lifecycle DocumentationTraceability MatrixRisk AssessmentsValidation Master PlansSoftware Development Lifecycle (SDLC)Agile MethodologiesValidation of Cloud-Based SystemsSaaS ApplicationsCommercial Off-The-Shelf (COTS) SoftwareISO 9001 Principles

Soft Skills

MentoringCollaborationTrainingLeadership

Tools & Technologies

CypressPlaywright

Industry Keywords

21 CFR Part 11EU Annex 11Regulated Life SciencesPharmaceutical IndustryBiotech IndustryMedical Device Industry

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 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 validation 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, validation testing, defect resolution, CAPA investigations, and audit responses
Collaborate with Quality Management to maintain 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 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

Benefits

Comp & perks

Remote-friendly environment
Equal opportunity workplace
Welcoming and supportive work environment
Collaborative global team
Tangible impact on scientific innovation