Lead Validation Engineer
New
D
DotmaticsScientific software
Remote - IrelandFull-TimeLead
Salary69,062 - 93,436 GBP per year
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Job Details
- Required Skills
- AgileCypressPlaywright
Requirements
- Bring deep working knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and GxP requirements as they apply to software systems.
- Have familiarity with ISO 9001 quality management system principles.
- Demonstrate experience authoring and executing IQ/OQ/PQ protocols, traceability matrices, and validation summary reports.
- Have experience using automated testing tools such as Cypress or Playwright to generate and capture test evidence.
- Understand the software development lifecycle (SDLC) and Agile methodologies.
- Have experience validating cloud-based systems, SaaS applications, or commercial off-the-shelf (COTS) software.
- A bachelor’s degree in Computer Science, Biology, Chemistry, Engineering, or a related field is preferred but not required.
- A background in a regulated life sciences environment, such as pharmaceutical, biotech, or medical device industries, is preferred.
Responsibilities
- Author, review, and approve validation lifecycle documentation, including Validation Master Plans, URS, FRS, traceability matrices, risk assessments, and IQ/OQ/PQ protocols and reports.
- Apply GAMP 5 principles and risk-based approaches to determine validation strategies and documentation requirements.
- Work with software quality and DevOps teams to develop, review, and run IQ/OQ/PQ protocols using automated tools such as Cypress.
- Serve as the Luma subject matter expert for GAMP 5, 21 CFR Part 11, EU Annex 11, and applicable ISO standards.
- Mentor junior validation team members and QA staff on validation methodologies and documentation practices.
- Provide engineers, QA analysts, and project managers with guidance and training on CSV principles, IQ/OQ/PQ expectations, and 21 CFR Part 11 controls.
- Support customer-facing validation activities and coordinate validation testing and defect resolution.
- Assist with CAPA investigations and audit responses, and collaborate with Quality Management on document control, periodic reviews, and audit readiness.
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