Quality Systems Engineer Laboratory Operations

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Job Description

The Future Begins Here

At Takeda, we are leading digital evolution and global transformation. By building innovative solutions and future-driven capabilities, we are improving the lives of millions of patients around the world.

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.

About the role

Member of the QC Lab Systems team. Manages set of projects and initiatives with the focus on Laboratory Information systems (such as Labware and MODA).

Enable Takeda QC Labs with global solutions specifically such as Labware LIMS and MODA.

How you will contribute

• The DDT Quality Systems Engineer Lab Systems is a bridge between the Business (Need) and the Technology (Solutions). The Business need can be anything about overall business requirement (Process, Organisation, Integration, etc.) and solutions can be about efficient use of technology (standard tools support by the QC Lab DDT group).
• The DDT Quality Systems Engineer is required to analyse, transform and ultimately resolve the business problems with the help of technology. End-to-end solution engineering (requirements → design → build/config → test/UAT → release.
• The DDT Quality Systems Engineer manages their work with limited supervision and is the technical lead for complex IT systems and projects.
• The DDT Quality Systems Engineer is responsible for support of the DDT systems owned by the group and will be part of the on-call support team once training is complete.
• 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.
• In depth understanding of Laboratory Systems.
• 5+ year experience using at least one of the following systems, MoDa, Labware
• Well-developed organizational skills and the ability to manage multiple projects simultaneously.
• Effectively interact with multifunctional teams
• Self-motivated and self-directed in driving results and deliverables
• Knowledge of Empower and Chromeleon as well as HPAlm (Application Lifecycle Management) testing tools, Jira, Toad and Powershell and other laboratory standard applicatio
• Experience with outsourced vendors a distinct advantage.
• Working knowledge of: SCRUM, Agile Methodologies, Change Management, Project Management
• Strong communication and interpersonal skills and proven experience in leading projects and management skills.
• 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)
• Experience in validated systems.

What Takeda’s ICC Can Offer You

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

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 Vouchers
• Flexible Working Schemes
• Comprehensive Healthcare Insurance Plans: Life, Medical, Dental & Vision
• Additional Time Off
• Diversity, Equity, and Inclusion Programs

Work Location: Naucalpan

Hybrid model with a minimum in-office requirement of at least 10 (ten) days per month.

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