[Hiring] Lead Validation Engineer @Dotmatics

Role Description

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), you will ensure 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
• ISO 9001

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.
• Work 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 11, 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.

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 commercial off-the-shelf (COTS) software.

Requirements

• Support customer-facing validation activities.
• Coordinate validation testing and defect resolution.
• Assist with CAPA investigations and audit responses.
• Collaborate with the Quality Management team to maintain document control, periodic reviews, and overall audit readiness for validation artefacts.

Benefits

Research shows us the confidence gap and imposter syndrome can get in the way of meeting outstanding candidates, so please don’t hesitate to apply — we’d love to hear from you.

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Dotmatics is an equal opportunity employer. We are a welcoming place for everyone, and we do our best to make sure all people feel supported and connected at work.