Senior Computer System Validation Engineer

Takeda; Ciudad de México; Presencial; MXN 400,000 - 600,000; Jornada completa

Descripción de la vacante

A leading global pharmaceutical company in Mexico City is seeking a candidate for an infrastructure qualification role. The ideal applicant has over 3 years of experience and a Bachelor's degree in a relevant field. Responsibilities include conducting qualification activities for IT systems and collaborating with multi-functional teams. Competitive salary and benefits offered, including healthcare and flexible working schemes.

Servicios

Competitive Salary + Performance Annual Bonus

Monthly Supermarket and Food Vouchers

Flexible Working Schemes

Comprehensive Healthcare Insurance Plans

Additional Time Off

Diversity, Equity, and Inclusion Program

Formación

• 3+ years of experience in a similar role.
• Proven experience in infrastructure qualification and computer system validation.
• In-depth knowledge of relevant regulations related to computer system validation.

Responsabilidades

• Conduct qualification activities for IT systems and infrastructure.
• Develop and execute validation protocols and test scripts.
• Collaborate with cross-functional teams on validation requirements.

Conocimientos

Analytical skills

Problem-solving skills

Excellent communication

Teamwork abilities

Attention to detail

Educación

Bachelor's degree in Computer Science, Engineering, or Life Sciences

Herramientas

GAMP 5

21 CFR Part 11

Descripción del empleo

Job Description

The Future Begins Here

At Takeda, we are leading digital evolution and global transformation. By building innovative solutions and future-ready capabilities, we are meeting the need of patients, our people, and the planet.

Mexico City has been selected to be home to Takeda’s recently launched Innovation Capability Center thanks to its international recognition in qualified and experienced talent in the data, digital and technology fields. We invite you to join our digital transformation journey.

In this role, you will have the opportunity to boost your skills and become the heart of an innovative engine that is contributing to global impact and improvement.

At Takeda’s ICC we Unite in Diversity

Takeda is committed to creating an inclusive and collaborative workplace, where individuals are recognized for their backgrounds and abilities they bring to our company. We are continuously improving our collaborators journey in Takeda, and we welcome applications from all qualified candidates. Here, you will feel welcomed, respected, and valued as an important contributor to our diverse team.

Key Responsibilities

• Conduct qualification activities for IT Systems, including infrastructure systems, including servers, network equipment, and cloud-based resources.
• Develop and execute validation protocols, test scripts, and documentation in accordance with industry standards and regulatory requirements.
• Collaborate with cross-functional teams to define validation requirements and ensure alignment with project goals.
• Perform risk assessments and impact assessments related to infrastructure changes.
• Investigate and resolve deviations, discrepancies, and non-conformances during validation activities.
• Maintain and update validation documentation to reflect system changes and updates.
• Stay current with industry trends and best practices related to infrastructure qualification and cloud technology.
• Provide training and guidance to team members on validation processes and procedures.

Qualifications

• 3+ years of experience in a similar role
• Bachelor's degree in a relevant field (e.g., Computer Science, Engineering, Life Sciences).
• Proven experience in infrastructure qualification and computer system validation.
• In-depth knowledge of relevant regulations, guidelines, and industry standards related to CSV, data integrity, and computerized systems (e.g., GAMP 5, 21 CFR Part 11).
• Familiarity with cloud qualification practices (nice to have).
• Strong analytical and problem-solving skills.
• Excellent communication and teamwork abilities.
• Attention to detail and a commitment to quality.

What Takeda’s ICC Can Offer You

Takeda is certified as a Top Employer, not only in México and North America, but also globally. No investment we make pays greater dividends than taking good care of our people.

At Takeda, you take the lead on building and shaping your own career.

Joining the ICC in Mexico City will give you access to high-end technology, continuous training and a diverse and inclusive network of colleagues who will support your career growth.

It is our priority to provide competitive compensation and a benefit package that bridges your personal life with your professional career. Amongst our benefits are:

• Competitive Salary + Performance Annual Bonus
• Monthly Supermarket and Food Vouchers
• Flexible Working Schemes
• Comprehensive Healthcare Insurance Plans: Life, Medical, Dental & Vision
• Additional Time Off
• Diversity, Equity, and Inclusion Program.

Locations

MEX - Santa Fe

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time