Test Validation Engineer

Are you ready to make an impact in a global, cutting-edge environment? Pharmetheus, a leader in pharmacometrics consultancy, is expanding! We are at the forefront of supporting drug development through quantitative analysis and are building out our software development capabilities. Join our dynamic System Development team as a Test & Validation Engineer, playing a pivotal role in ensuring software quality during sprint cycles and driving validation activities for our GxP-regulated platform. About the role As a Test & Validation Engineer at Pharmetheus, you will be at the core of embedded software quality and regulatory compliance. Your role will involve driving high standards of quality across the entire software development life cycle. On a day-to-day level, you will work closely with our software developers and Product Owner to design and execute tests for incoming user stories. Simultaneously, you will champion compliance and validation for our flagship regulated software, ensuring all validation activities strictly follow the GAMP5 framework and relevant GxP standards. You won't just be executing test scripts—you'll serve as the bridge between technical feature delivery and pharmaceutical compliance, ensuring our quantitative software solutions remain reliable, compliant, and ready to support critical drug development decisions. Responsibilities

• Perform continuous functional, integration, and regression testing as part of agile user story verification and acceptance.
• Author, maintain, and execute test plans, test suites, and test cases in collaboration with developers and Product Owner.
• Lead Systems Validation activities for our regulated software platform, following the GAMP5 risk-based framework.
• Generate and manage some core GAMP5 validation deliverables, including Test Plans, Test Specification and Requirements Traceability Matrices (RTM).
• Collaborate closely with the System Development team and QA functions to log, track, and re-test software defects.
• Identify quality risks and establish automated or streamlined testing practices to optimize release workflows.
• Ensure all documentation aligns with internal Quality Management System (QMS) standards and regulatory expectations.

Qualifications To fit in this position, you have a Bachelor’s degree in Computer Science, Software Engineering, or a related technical discipline. You bring several years of hands-on experience in software quality assurance, functional testing, and test case creation within agile environments. You have direct experience working with computer systems validation in regulated environments (e.g. GxP, 21 CFR Part 11 / EU Annex 11). Fluent command of English is required. Additional experience from the pharmaceutical industry, biotech, or GAMP5 framework will make you stand out. Familiarity with modern automated testing frameworks, the Atlassian suite (Jira, Confluence, Xray), and GAMP5 experience will give you an edge. Required Skills

• Bachelor’s degree in Computer Science, Engineering, or equivalent experience.
• 3+ years of experience in Software Testing / QA Engineering within agile software development cycles.
• Practical experience conducting software validation in a regulated environment.
• Strong capability in authoring high-quality test cases, test protocols, and validation documentation.
• Solid understanding of software development life cycle (SDLC) best practices and defect tracking workflows.
• Strong analytical skills with precise attention to detail and process compliance.
• Fluent in English (written and spoken).

Preferred Skills

• Experience with the GAMP5 framework, CFR 21 part 11, Annex 11 or GxP
• Experience in the pharmaceutical sector.
• Hands-on experience with test automation frameworks
• Familiarity with the Atlassian suite (Jira, Confluence) and test management tools (XRay).
• Understanding of continuous integration (CI/CD) pipelines and automated quality gates.

Equal Opportunity Statement Pharmetheus is committed to diversity and inclusivity in its hiring practices. Contact Selection is ongoing, and we encourage you to submit your application as soon as possible If you have questions regarding the role, please contact System Development Team Leader, Alexis Boucharin, alexis.boucharin@pharmetheus.com If you have questions about the recruitment process or status, please contact our HR Specialist, Sofia Englund at sofia.englund@pharmetheus.com This is a full-time, permanent position (100%) based primarily at our Uppsala or Gothenburg offices with flexible remote work options, though for the right candidate, the role can also be fully home-based anywhere within the EU. About Pharmetheus Pharmetheus is a consultancy firm specializing in the application of quantitative methods to support drug research, development, and life-cycle decisions, with a focus on improving patients' lives. Founded in 2012 by a team of experienced consultants, pharmaceutical industry leaders, and academic researchers, the company supports Model-Informed Drug Development (MIDD) across all stages of drug development and therapeutic areas. Pharmetheus provides tailored analyses to aid in crucial drug-related decisions, including dose selection and pediatric development planning. Committed to professionalism, Pharmetheus emphasizes transparency in its recruitment process and advises candidates to verify offers through official channels. Learn more at www.pharmetheus.com -