Senior Computer System Validation Engineer (Hybrid)

Takeda; Ciudad de México; Híbrido; MXN 400.000 - 640.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive salary + annual bonus

Meal vouchers (monthly)

Flexible work arrangements

Healthcare coverage

Descripción de la vacante

Takeda is seeking an experienced Validation Specialist to lead computer system validation and infrastructure qualification for our IT platforms in Mexico City. You will develop validation documentation, oversee planning, and drive remediation across projects while ensuring compliance with GAMP 5, FDA, and EU GxP standards.

The role requires hands-on experience, strong analytical and communication skills, and the ability to collaborate with cross-functional teams in a hybrid work model in Mexico

Formación

• Bachelor's degree in a relevant field (CS, Engineering, Life Sciences).
• Minimum 3 years in a similar computer system validation or infrastructure qualification role.
• Solid knowledge of GAMP 5 and 21 CFR Part 11.
• Familiarity with agile tools (JIRA, Confluence, qTest).

Responsabilidades

• Develop and oversee validation documentation (Validation Plans, URS, FS, IQ/OQ/PQ, validation reports).
• Lead validation planning, execution, and reporting with risk assessments and remediation.
• Provide guidance on validation testing methodologies and ensure regulatory compliance.
• Lead qualification activities for IT platforms, servers, networks, and cloud solutions.
• Collaborate with cross-functional teams to align validation activities with project goals.
• Support operations of applications and infrastructure, including change management.
• Investigate deviations and maintain validation documentation reflecting system changes.
• Stay current with ISPE GAMP, FDA/EU GxP, and ISO standards.
• Provide training and guidance to team on validation processes.

Conocimientos

Analytical skills

Communication

Team collaboration

Quality mindset

Educación

Bachelor's degree in Computer Science / Engineering / Life Sciences

Herramientas

JIRA

Confluence

qTest

Descripción del empleo

Takeda is seeking an experienced Validation Specialist to lead computer system validation and infrastructure qualification for our IT platforms in Mexico City. You will develop validation documentation, oversee planning, and drive remediation across projects while ensuring compliance with GAMP 5, FDA, and EU GxP standards.

The role requires hands-on experience, strong analytical and communication skills, and the ability to collaborate with cross-functional teams in a hybrid work model in Mexico