Test Engineer

Project overview

This contract Test Engineer role validates GxP computerized systems used in technical development and R&D, including data platforms, cloud infrastructure, automation frameworks, and AI-based applications. The key requirements are a relevant degree, at least two years of testing computerized systems in a regulated environment, knowledge of CSV and ALCOA+ data integrity principles, familiarity with EU GMP Annex 11, 21 CFR Part 11 and GAMP 5, plus practical SQL and cloud experience.

The engineer will develop and execute manual and automated tests, create inspection-ready validation evidence, verify data pipelines and warehouses, and manage traceability and defects in an ALM or test management tool. Python or Robot Framework, AI/ML testing, Snowflake, AWS, Airflow, ServiceNow, Veeva Vault, and audit experience are beneficial. The structured experience band is 3–10 years, while the description sets a minimum of 2+ years; the locations are Poland and Spain, and work mode is not specified.

Responsibilities

• (Ideally it should not be more than 3-5)
• Degree in engineering, computer science, life sciences or a related field.
• 2+ years testing computerized systems in a GxP or other regulated environment, Manual/Automation Testing.
• Working knowledge of computerized system validation and data integrity principles (ALCOA+).
• Familiarity with EU GMP Annex 11, 21 CFR Part 11 and GAMP 5 categorization.
• Practical SQL skills and comfort working with cloud services.
• Experience in managing test cases, executions and defects in test management or ALM tool (e.g. Jira/XRay, ServiceNow, etc.)
• Excellent verbal and written communication skills with the ability to clearly communicate complex solutions to audiences with varying technical experience and seniority.
• Able to work effectively in cross-functional teams, both co-located and remote, collaborating across sites and time zones to deliver shared milestones.
• Able to adapt quickly in a changing environment, with shifting priorities and evolving requirements.
• Willingness to learn new systems, tools and regulatory expectations, and to build domain knowledge in different business areas.
• Ø Technical Development (R&D): Clinical trial data, Process development, Active ingredient data, Knowledge graphs, Substance properties.

Requirements

• Degree in engineering, computer science, life sciences, or a related field
• At least 2 years testing computerized systems in a GxP or other regulated environment, using manual and/or automated testing
• Working knowledge of computerized system validation (CSV)
• Knowledge of data integrity principles, including ALCOA+
• Familiarity with EU GMP Annex 11, 21 CFR Part 11, and GAMP 5 categorization
• Practical SQL skills
• Comfort working with cloud services
• Experience managing test cases, executions, and defects in a test management or ALM tool
• Strong verbal and written communication skills
• Ability to collaborate effectively in cross-functional, distributed teams
• Ability to adapt to changing environments, priorities, and requirements
• Willingness to learn new systems, tools, regulatory expectations, and business domains

Project details

• Start: flexible
• Remote: hybrid
• Location: Poland, Spain, GB