About the Role

We are seeking experienced Test Engineers to join a integral team responsible for testing and validating regulated digital solutions used across Research & Development environments. You will play a key role in ensuring GxP-compliant computerized systems, cloud platforms, data solutions, and AI-enabled applications are fit for purpose, inspection-ready, and aligned with industry regulatory standards.

This is an excellent opportunity for testing professionals with experience in regulated environments who are passionate about quality, compliance, data integrity, and modern testing practices.

Key Responsibilities

- Author and maintain test strategies, test plans, qualification protocols, and test summary reports.
- Apply risk-based testing approaches to define appropriate test scope, depth, and sampling strategies.
- Design and execute manual and automated test cases aligned to business and user requirements.
- Validate system functionality, boundary conditions, error handling, security controls, and data integrity requirements.
- Execute testing activities in validated environments and produce compliant, audit-ready evidence.
- Develop and perform SQL-based data validation checks across data pipelines and data warehouses.
- Manage test assets, executions, defects, and traceability within test management platforms.
- Perform root-cause analysis and drive issues through to resolution.
- Maintain complete traceability from requirements through executed test results.
- Review requirements, architecture, and design documentation and identify gaps before validation activities begin.
- Collaborate with validation leads, system owners, architects, developers,



DevOps engineers, data engineers, data scientists, and QA stakeholders.
- Support validation activities for GxP systems, cloud infrastructure, automated testing frameworks, data platforms, and AI-driven applications.

Required Skills & Experience

- Degree in Engineering, Computer Science, Life Sciences, or a related discipline.
- 2 years of experience testing computerized systems within a GxP or regulated environment.
- Strong experience with Manual Testing and/or Automation Testing.
- Working knowledge of computerized system validation (CSV) and data integrity principles (ALCOA ).
- Familiarity with:
- EU GMP Annex 11
- 21 CFR Part 11
- GAMP 5
- Practical SQL skills and experience working with cloud-based environments.
- Experience using test management or ALM tools such as Jira/XRay, ServiceNow, or similar.
- Excellent communication and stakeholder management skills.
- Ability to work effectively within distributed, cross-functional global teams.
- Strong adaptability, problem-solving ability, and willingness to learn new technologies and regulatory requirements.

Domain Experience

Experience supporting R&D; or scientific data platforms involving any of the following is highly valued:

- Clinical Trial Data
- Process Development
- Active Ingredient Data
- Knowledge Graphs
- Substance Properties

Nice to Have

- Experience testing AI or Machine Learning solutions.
- Test automation experience using Python, Robot Framework, or similar technologies.
- Exposure to tools such as:
- Snowflake
- AWS
- Airflow
- ServiceNow
- Veeva Vault
- Previous involvement in regulatory inspections, audits, or compliance reviews.

📌 Tester (México)
🏢 Templeton u0026 Partners - Innovative u0026 Inclusive Hiring Solutions
📍 México