Senior Computer System Validation Lead (Regulatory IT)

MEX - 9930 Takeda Innovation Solutions Mexico S.A de C.V; Santa Fe; Híbrido; MXN 600.000 - 840.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Flexible work arrangements

Healthcare: Medical, Dental, Vision

Restaurant/meal vouchers

Descripción de la vacante

Takeda is seeking a validation professional to develop and oversee validation documentation for IT platforms and infrastructure in Mexico City. You will lead planning, execution, and reporting, ensuring compliance with GAMP 5, 21 CFR Part 11, and related standards.

You will collaborate with cross-functional teams, mentor others, and drive remediation of issues while maintaining up-to-date validation records. The role supports a hybrid work model in Santa Fe.

Formación

• Minimum of 3 years of experience in a similar role.
• Bachelor's degree in Computer Science, Engineering, or Life Sciences.
• Proven experience in computer system validation and infrastructure qualification.
• Familiarity with cloud qualification practices preferred.
• Working knowledge of agile environments and modern quality tools (e.g. JIRA, Confluence, qTest).
• GAMP 5 and 21 CFR Part 11 knowledge.

Responsabilidades

• 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 remediation of issues.
• Provide guidance on validation testing methodologies, including test design, execution, and documentation.
• Ensure 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 during validation and operations.
• Maintain and update validation documentation to reflect system changes and updates.
• Stay current with ISPE GAMP, FDA and EU GxP regulations, and ISO standards.
• Provide training and guidance to team members on validation processes and procedures.

Conocimientos

Analytical thinking

Problem-solving

Communication

Teamwork

Attention to detail

Educación

Bachelor's in Computer Science / Engineering / Life Sciences

Herramientas

JIRA

Confluence

qTest

Descripción del empleo

Takeda is seeking a validation professional to develop and oversee validation documentation for IT platforms and infrastructure in Mexico City. You will lead planning, execution, and reporting, ensuring compliance with GAMP 5, 21 CFR Part 11, and related standards.

You will collaborate with cross-functional teams, mentor others, and drive remediation of issues while maintaining up-to-date validation records. The role supports a hybrid work model in Santa Fe.