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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

📌 Sr. Computer System Validation Engineer (Ciudad de México)
🏢 Takeda
📍 Ciudad de México