Lead CSV & GxP Validation Engineer (SaaS)

Dotmatics Ltd.; Ireland; Hybrid; EUR 85,000 - 120,000; Full time

Job summary

Dotmatics Ltd. in Ireland is seeking a Validation Lead to manage validation activities for the Luma platform and internal systems under GxP requirements. This role focuses on ensuring CSV compliance across software development, testing and release processes.

You will partner with Product, Engineering, and Quality Management teams to drive validation best practices through the SDLC, authoring documentation and ensuring audit-ready deliverables for customers and regulators.

Qualifications

• 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 COTS software.

Responsibilities

• 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.
• 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.
• We are looking for people who can support customer-facing validation activities, coordinate validation testing and defect resolution, assist with CAPA investigations and audit responses, and collaborate with the Quality Management team to maintain document control, periodic reviews, and overall audit readiness for validation artefacts.

Skills

GxP knowledge

Regulatory compliance

CSV validation

IQ/OQ/PQ

Automated testing

SDLC/Agile

Education

Bachelor's degree in CS/Related field

Background in regulated life sciences

Tools

Cypress

Playwright

Job description

Dotmatics Ltd. in Ireland is seeking a Validation Lead to manage validation activities for the Luma platform and internal systems under GxP requirements. This role focuses on ensuring CSV compliance across software development, testing and release processes.

You will partner with Product, Engineering, and Quality Management teams to drive validation best practices through the SDLC, authoring documentation and ensuring audit-ready deliverables for customers and regulators.