Lead Validation Engineer | Luma

What do we need:

As a Validation Lead, you will be responsible for leading validation activities for the Dotmatics Luma platform and its internal systems operating under GxP requirements. Serving as the subject matter expert for computer system validation (CSV) and ensures that software development, testing, and release activities comply with applicable regulations and standards including 21 CFR Part 11, EU Annex 11, GAMP 5, ICH Q10, and ISO 9001 as applicable.

The Validation Lead partners closely with Product, Engineering, and Quality Management teams to drive validation best practices throughout the software development lifecycle (SDLC), ensuring traceable, audit ready deliverables that meet customer and regulatory expectations.

In this role you will get to:

• 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.

The key skills we are looking for:

• 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

You may also have:

• 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.