Sr. Computer System Validation Engineer

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

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.
• Strong analytical and problem-solving skills.
• Excellent communication and teamwork abilities.
• Attention to detail and a strong commitment to quality.

What Takeda can offer you:

• Competitive salary + annual performance bonus
• Monthly restaurant and meal vouchers
• Flexible work arrangements
• Comprehensive Healthcare: Medical, Dental, and Vision
• Among other benefits

More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Empowering our people to shine: Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.

Work Location: Mexico City - Santa Fe. Hybrid model with a minimum in-office requirement of at least 10 (ten) days per month. Locations MEX - Santa Fe Worker Type Employee Worker Sub-Type Regular Time Type Full time

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism - Integrity, Fairness, Honesty, and Perseverance - and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people's lives - including your own. Takeda is an equal opportunity employer.