Software Validation Engineer (QA)

About us

the company’s mission is to accelerate clinical trials and ensure breakthroughs in lung and heart disease reach patients without delay. Our AI-powered data and imaging curation platform enables the analysis of clinical imaging and other healthcare data, helping our customers bring treatments to market, faster.

We’re looking for talented people who want their work to matter. With offices in Cambridge and London, you’ll join our multidisciplinary team of clinicians, scientists, and engineers. What unites us is our open culture, continuous learning mindset, and a shared mission to help biopharma run faster, smarter trials.

About the role

We are seeking an early-career or graduate software validation engineer to join our team at the company. In this role, you will help us deliver the highest quality products to our clinical trial customers and meet our regulatory requirements. To succeed, you must have experience working with automated testing frameworks, an eye for identifying critical product issues, and an attention to detail.

At the company, we have developed a cloud-based platform that is used by our pharmaceutical and biotech clients to curate and analyse data from clinical drug trials using advanced machine learning techniques.

In this role, you will help deliver our testing and validation strategy, working across a Python backend, Next.js front end, deep-learning vision models (pytorch) and Terraform’ed EKS environment on AWS.

Key responsibilities

Product Development

• Help implement testing strategies across the company’s integrated software stack, including automated unit, integration, regression and E2E tests.
• Ensure that all functional, performance, regulatory, privacy and security requirements are tested to an acceptable level prior to product release.
• Manage test runs; identifying, reporting and tracking any software defects that arise.
• Participate in software design reviews, helping to ensure that all software requirements are clear, concise and testable.
• Contribute to the ongoing improvement of automated processes that produce traceable artefacts.
• Attend sprint planning and stand-up meetings to stay apprised of new feature development work

Business Systems Validation

• Contribute to risk-based computer systems validation (CSV) across a range of commercial and in-house software platforms to ensure compliance with clinical trial, quality and regulatory standards, particularly Good Clinical Practice and GAMP 5. (You don’t need to be an expert in this; we’ll provided training and guidance)

Quality Assurance

• Be proactive in suggesting improvements that improve product quality and our way of working.
• Remain up to date with the latest best practices and testing methodologies and frameworks.

Requirements

• Industry experience in software testing (preferably for a cloud-hosted product suite), through previous roles, internships or projects.
• You have experience validating python-based software stacks; familiarity with systems that include machine learning components is advantageous.
• You are skilled in the use of common test frameworks and tools such as pytest, Playwright, Selenium, etc and experienced in the use of CI/CD tools (we use Gitlab).
• You have excellent problem-solving skills, an analytical mindset and strong communication skills.

It’s a bonus if you have (but not essential):

• You have experience or knowledge (through training or education) of software validation in a regulated industry. (Our software platform is developed under a ISO 13485 certified quality management system, and GxP-validated following GAMP 5 methodology).
• Knowledge formal Computer Systems Validation/Assurance methodologies, e.g, GAMP 5.
• A degree or degree-equivalent in a relevant scientific or technical area, e.g. computer science or engineering, is beneficial, but not essential.

Benefits What can you expect from us

• A comprehensive benefits package that includes an annual bonus plan, private medical insurance, life insurance, and a contributory pension scheme
• 25 days annual leave, plus bank holidays and enhanced maternity leave
• A diverse work environment that brings together experts in many fields, including software engineering, devops, data science, machine learning, quality assurance, regulatory affairs, and clinical operations.

If you have any queries, please contact Everyone is welcome at the company. We are an equal opportunities employer and encourage applications from all suitably qualified candidates regardless of age, disability, ethnicity, sex, gender reassignment, religion or belief, sexual orientation, marriage and civil partnership, or pregnancy and maternity.

Women and other underrepresented groups may be less likely to apply for a role unless they meet all or nearly all of the requirements. If this applies to you, we still encourage you to apply – you may be a great fit, even if you don’t meet every qualification. We’d love to hear from you.

If you require any adjustments to the application or selection process, please let us know. We will be happy to support you.

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