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ValGenesis

Posted 3 months ago

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Test Engineer, Functional

LisbonOn-siteFull-time

AI Summary

A Test Engineer, Functional designs, executes, and manages functional and regression testing for enterprise software in regulated life sciences environments, ensuring compliance and quality across development lifecycle.

About this role

ValGenesis is a leading digital validation platform provider for life sciences companies. ValGenesis suite of products are used by 30 of the top 50 global pharmaceutical and biotech companies to achieve digital transformation, total compliance and manufacturing excellence/intelligence across their product lifecycle.
Learn more about working for ValGenesis, the de facto standard for paperless validation in Life Sciences: https://www.valgenesis.com/about

Requirements:

  • 2 to 6 years of experience with enterprise software product development lifecycle/phases.

  • Strong experience in Functional testing of all test phases, including test strategy, test design.

  • Solid understanding of GxP regulations and 21 CFR Part 11 / EU Annex 11 compliance and familiarity with Validation Protocols (IQ, OQ, PQ) is a plus.

  • Previous experience working within the Pharmaceutical, Biotech, or Medical Devices industries is highly valued.

  • Experience using Jira and Test Management tools (e.g., Xray, Zephyr) to manage regulated documentation.

  • Able to work collaboratively and independently with speed and minimal supervision.

  • Experience/knowledge in pharma regulatory, quality, risk, process validation software systems (e.g., GAMP 5 framework)

  • Experience with AI powered automation frameworks like Playwright, TestRigoretc is preferable.

Responsibilities:

  • Develop deep expertise in our products and their uses in the pharmaceutical industry.

  • Plan and execute enterprise software platform integration, system testing activities

  • Work with software developers and product managers in an Agile team environment.

  • Create and Manage test repository (scenarios, cases, steps, priorities, categories etc), test metrics, maintaining full traceability between requirements and test cases (Traceability Matrix).

  • Ability to map data flows in the software as a basis to develop challenging and robust testing.

  • Conduct QA tests and verify outcomes within schedules/timelines.

  • Part of a team (BA/PO, Developers, SDETs etc) that develop enterprise software applications.

  • Understand the business requirements and design, development/coding aspects.

  • Participate in the complete development life cycle

  • Use AI tools/capabilities to automate the generation, automation, execution of test suites

  • Performing test automation on multiple application platforms – Web, Mobile et

  • Manage/Involve with CI/CD specific activities.

  • Own and be accountable for the Quality, Reliability and Compliance of the respective product deliverables.

  • Strive for self-excellence along with enabling success of the team/stakeholders.

Skills

21 CFR Part 11AI Automation FrameworksEU Annex 11Functional TestingGAMP 5GxPIQ OQ PQJiraPlaywrightTest DesignTestrigorTest StrategyXrayZephyr

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