Job Description

How you will contribute:
- Develop and oversee validation documentation, including Validation Plans, URS, FS, IQ/OQ/PQ protocols, validation reports, and traceability matrices.
- Lead validation planning, execution, and reporting across the organization, including risk assessments, validation deliverables, documentation updates, and driving remediation of issues.
- Provide guidance on validation testing methodologies, including test design, execution, and documentation. Ensure that testing meets regulatory expectations
- Lead and perform qualification activities for IT Platforms and infrastructure, including servers, network equipment, and cloud-based solutions.
- Collaborate with cross-functional teams to define validation requirements and align validation activities with project goals.
- Support Operations of Applications and infrastructure, including change management, system releases, periodic reviews.
- Investigate and resolve deviations, discrepancies, and non-conformances identified during validation and operational activities.




- Maintain and update validation documentation to reflect system changes and updates.
- Practice and stay current with ISPE GAMP best practices, FDA and EU GxP regulations, and applicable ISO standards.
- Provide training and guidance to team members on validation processes and procedures.

What you bring to Takeda:
- Minimum of three years of experience in a similar role.
- Bachelor's degree in a relevant field, such as Computer Science, Engineering, or Life Sciences.
- Proven experience in computer system validation and infrastructure qualification
- In-depth knowledge of applicable regulations, guidelines, and industry standards related to computer system validation, data integrity, and computerized systems, including GAMP 5 and 21 CFR Part 11.
- Working Knowledge of agile environment and use of modern quality tools (e.g. JIRA, Confluence, qTest, etc)
- Familiarity with cloud qualification practices is preferred.
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📌 Sr. Computer System Validation Engineer (Ciudad de México)
🏢 Takeda
📍 Ciudad de México