Quality Systems Engineer Laboratory Systems

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Job Description

About the role:

The DDT Quality Systems Engineer – Lab Systems acts as a key liaison between business needs and technology solutions, translating laboratory and quality business requirements into end-to-end IT solutions. The role involves leading the full solution lifecycle—from requirements analysis and design through build/configuration, testing (UAT), and release—ensuring effective use of standard QC Lab DDT technologies. Working with limited supervision, the engineer serves as the technical lead for complex systems and projects, and is responsible for the ongoing support of DDT-owned lab systems, including participation in the on-call support rotation once fully trained.

How you will contribute:

• Understand and analyze requirements for Chromatography instrumentation especially using knowledge of Empower and Chromeleon systems to implement solutions.
• Work with the Takeda laboratories to help them understand their requirements around the following workflows: Environmental Monitoring, Raw Materials receiving and inspection, Standards and reagent management and testing, Lot/batch QC testing and release, stability testing of products, test instrument management.
• Assess proposed solutions to help the stakeholders select the solution which best fits their requirements.
• Plan the tasks and activities for Business Analysis including stakeholder analysis, managing issues, risks and requirements, and monitoring and reporting on business analysis activities.
• You will oversee and participate in the architectural design, development, customization and integration efforts.
• Provide oversight of vendor-provided solutions and handle ad-hoc technical requests from both internal and external partners

What you bring to Takeda:

• Bachelor's degree preferred or relevant work experience in systems or business.
• Ability to write and speak in the English language.
• 5+ year experience using at least one of the following systems: Empower, Chromeleon.
• Working knowledge of: SCRUM, Agile Methodologies, Change Management, Project Management
• Strong communication and leadership skills, with proven ability to build relationships and lead initiatives with cross-functional stakeholders.
• Gather, understand, and document business processes, objectives, specifications, and requirements on medium/large size projects.
• GxP/CSV validation delivery for lab systems (21 CFR Part 11, EU Annex 11, data integrity/ALCOA+, audit readiness)
• Technical/Functional (Line) Expertise
• Technical experience with Empower, Chromeleon, Lab Instrument Interfacing
• System administration & configuration (projects/methods, user roles/permissions, audit trails, e-signatures, templates, calculations)
• Incident/problem management for lab-critical systems (triage, root cause, CAPA, vendor escalation, on-call readiness)
• Self-driven, hands-on professional able to manage multiple priorities and deliver high-quality results under pressure.

What Takeda can offer you:

At Takeda, you shape your own career path. By joining the ICC in Mexico City, you’ll gain access to cutting-edge technology, continuous learning, and a diverse network that supports your growth.

We also offer a competitive compensation and benefits package designed to support your personal and professional life, including:

• Competitive salary + annual performance bonus

• Monthly supermarket and meal vouchers

• Non-capped food vouchers and savings fund contributions

• Flexible work arrangements

• Comprehensive insurance: life, medical, dental & vision

• Additional paid time off

• Diversity, Equity & Inclusion programs

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.

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