Validation Engineer

🔥 21 minutes ago

🇬🇧 United Kingdom – Remote

💵 £50.5k - £68.3k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👷🏻‍♀️ Engineer

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This company has sponsored UK Skilled Worker visas in the past.

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Dotmatics

WebsiteLinkedInAll Job Openings

501 - 1000 employees

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

Dotmatics is an AI-powered scientific intelligence platform that specializes in data management and workflow automation specifically for multimodal scientific discovery. It facilitates adaptive lab workflows, enhances collaboration across various scientific disciplines, and integrates advanced predictive analytics to accelerate research and development. With a suite of products, including solutions for bioinformatics, cheminformatics, and flow cytometry, Dotmatics supports researchers in making informed decisions, streamlining operations, and driving innovation in drug discovery and materials science.

📋 Description

• Execute and contribute to validation activities for the Dotmatics Luma platform and internal systems operating under GxP requirements • Ensure software development, testing, and release activities comply with 21 CFR Part 11, EU Annex 11, GAMP 5, ICH Q10, and applicable ISO 9001 standards • Use AI tools to accelerate validation work and manage product requirements • Partner with Product, Engineering, and Quality Management throughout the software development lifecycle • Author and review Validation Master Plans, URS, FRS, Traceability Matrices, Risk Assessments, IQ, OQ, and PQ protocols and reports • Gather, document, and manage product requirements in Jira and Confluence • Develop, review, and run IQ, OQ, and PQ protocols using automated tools such as Cypress • Apply GAMP 5 to determine validation strategies and documentation requirements • Support and share knowledge with junior validation team members and QA staff • Provide validation guidance and training to engineers, QA analysts, and project managers • Support customer-facing validation activities, coordinate testing and defect resolution, assist with CAPA investigations and audit responses • Collaborate with Quality Management to maintain document control, periodic reviews, and audit readiness

🎯 Requirements

• Approximately 5 years’ experience in computer system validation, software quality assurance, or a related role, ideally within a GxP-regulated environment • Solid 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 • Experience with automated testing tools such as Cypress or Playwright • Understanding of software development lifecycle (SDLC) and Agile methodologies • Hands-on experience using AI tools, such as generative AI assistants, with responsible-use, data-confidentiality, and human-review awareness • Product management skills for eliciting and writing clear, testable requirements and user stories, refining and prioritizing backlogs, and using Jira, Confluence, or similar tools • Experience validating cloud-based systems, SaaS applications, or COTS software • 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 may be beneficial • Ability to support customer-facing validation activities, coordinate validation testing and defect resolution, assist with CAPA investigations and audit responses, and collaborate with Quality Management

🏖️ Benefits

• Remote-friendly environment • Equal opportunity workplace • Supportive and connected work environment

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