Lead Validation Engineer - Luma

dotmatics; United Kingdom; Remote; GBP 70.000 - 100.000; Vollzeit

Zusammenfassung

Dotmatics is seeking a Validation Lead to drive validation activities for the Luma platform and internal systems, ensuring compliance with GxP requirements, 21 CFR Part 11, EU Annex 11, and ISO standards. You will partner with Product, Engineering, and Quality Management to embed validated processes across the SDLC in a remote-friendly environment.

Lead the creation and approval of validation documents, supervise IQ/OQ/PQ execution, and mentor junior staff.

Qualifikationen

• Deep working knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and GxP requirements for software systems.
• Familiarity with ISO 9001 Quality Management System principles.
• Experience authoring/executing IQ/OQ/PQ protocols, traceability matrices, and validation reports; using automated testing tools.

Aufgaben

• Author, review, and approve validation lifecycle docs (Validation Master Plans, URS, FRS, Traceability Matrix, Risk Assessments, IQ/OQ/PQ)
• Collaborate with software quality and devops to leverage automated tools to develop and run protocols
• Apply GAMP 5 framework to determine validation strategies and documentation requirements
• Mentor junior validation staff on methodologies and documentation best practices
• Provide validation guidance to engineers, QA analysts, and project managers on CSV principles and 21 CFR Part 11 controls
• Support customer-facing validation activities, coordinate testing and defect resolution, assist CAPA investigations and audit responses

Kenntnisse

GAMP 5 knowledge

21 CFR Part 11

EU Annex 11

GxP software validation

SDLC & Agile

Ausbildung

Bachelor's degree in CS/Engineering/Biology or related (preferred)

Tools

Cypress

Playwright

Jobbeschreibung

Our Why At Dotmatics

At Dotmatics, a Siemens company, we believe science, data, and decision-making must be deeply intertwined for innovation to thrive. Our Portfolio includes Luma, LumaLab Connect, ELN Platform, Graphpad Prism, Geneious, SnapGene, Protein Metrics, OMIQ, FCS Express, LabArchives, NQuery, EasyPanel, SoftGenetics and Virscidian.

We have a vision for a new Lab of the Future that will change the future of scientific research.

We have created the world's most comprehensive digital science platform - best-of-breed software applications already used by more than 2 million scientists, together in a single ecosystem united by a powerful, flexible enterprise data platform. This is not flat data buried away in digital graveyards. This is dynamic, multi-dimensional decision-making.

Scientific enterprises need a new level of effectiveness to achieve tomorrow's breakthroughs. Illness will not wait. The biosphere will not wait. We are tireless in our vision, because the time for innovation is now.

Shaping the Future of Science At Dotmatics

Our global team of more than 800 colleagues are dedicated to supporting our customers in over 180 countries. Together, with our scientific community of users, we accelerate scientific innovation in order to make the world a healthier, cleaner, and safer place to live.

You’ll join a collaborative, global team pushing the boundaries of scientific innovation. Your ideas and efforts will have a tangible impact, accelerating scientific progress and discovery. We offer a dynamic, remote-friendly environment that fosters high integrity and collaboration, empowering you to excel. Dotmatics is a company built by scientists, for scientists. Combined, we are now the world's largest cloud-based scientific research R&D platform. We need your help to keep growing and pioneering the future.

We are Science Driven. We are Customer Centric. We are Better Together.

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.