Luma Validation Lead, GxP & 21 CFR Part 11 SaaS

Dotmatics Ltd.; Ireland; Remote; EUR 70,000 - 100,000; Full time

Job summary

Dotmatics, a Siemens company, is seeking a Validation Lead to spearhead validation activities for the Luma platform and internal systems under GxP requirements.

You will partner with Product, Engineering and Quality Management to drive best practices across the SDLC, ensuring audit-ready deliverables and regulatory compliance.

Experience with IQ/OQ/PQ, risk assessments, and use of automated testing tools like Cypress or Playwright is highly valued.

Qualifications

• Must be a CSV/validation SME with knowledge of GxP and regulatory standards.
• Experience authoring IQ/OQ/PQ protocols and traceability matrices.
• Familiar with SDLC and Agile; able to drive validated deliverables and audits.

Responsibilities

• Lead validation activities for the Dotmatics Luma platform and internal systems under GxP.
• Collaborate with Product, Engineering, and Quality Management to implement validation best practices across SDLC.
• Create and review Validation Master Plans, URS, FRS, Traceability Matrix, IQ/OQ/PQ protocols, and reports.

Skills

GxP regulations

CSV (computer system validation)

GAMP 5

21 CFR Part 11

EU Annex 11

IQ/OQ/PQ protocols

SDLC

Agile

Cypress

Playwright

Education

Bachelor’s degree in Computer Science, Biology, Chemistry, Engineering

Tools

Cypress

Playwright

Job description

Dotmatics, a Siemens company, is seeking a Validation Lead to spearhead validation activities for the Luma platform and internal systems under GxP requirements.

You will partner with Product, Engineering and Quality Management to drive best practices across the SDLC, ensuring audit-ready deliverables and regulatory compliance.

Experience with IQ/OQ/PQ, risk assessments, and use of automated testing tools like Cypress or Playwright is highly valued.