QC Labs Application Engineer (LIMS/EMPOWER) (Ciudad de Mexico, Ciudad de México, MX, 01210)

About Astellas

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need.  Learn more at Astellas.com .

Are you driven to make a real difference in the lives of patients? 

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

Astellas’ Global Capability Centres – Overview

Astellas’ Global Capability Centres (GCCs) are strategically located sites that give Astellas the ability to access talent across various functions in the value chain and to co-locate core capabilities that are currently dispersed. Our three GCCs are located in India, Poland and Mexico.

The GCCs will enhance our operational efficiency, resilience and innovation potential, enabling a timely response to changing business demands.

Our GCCs are an integral part of Astellas, guided by our shared values and behaviors, and are critical enablers of the company’s strategic priorities, sustainable growth, and commitment to turn innovative science into VALUE for patients

Working Environment and Location

This position is based in Mexico City (Santa Fe area) and will require on-site work in a hybrid set up.

At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.

Purpose and Scope

A Global QC Labs Application Engineer is the Subject Matter Expert focused on the system administration, maintenance and enhancements to facilitate changes to laboratory systems and business processes in a complex Scientific IT landscape to ensure proper operation of GxP and non-GxP systems. Typical systems like Chromatography Data Systems (CDS), Scientific Data Management Systems (SDMS), Laboratory Information Management Systems (LIMS), Electronic Lab Notebook (ELN) and capacity management and resource scheduling systems within the Manufacturing QC labs are part of your knowledge, experience and skillset.

This role is responsible for the configuration, maintenance, integration, and support of laboratory systems to ensure compliance, efficiency, and reliability in a regulated (GxP) environment, with openness to hiring motivated individuals who are eager to learn.

Role and Responsibilities

Be the first point of contact for key users in the QC labs of the lab systems and provide technical support, triage issues and requests

Work closely together with your direct colleagues and team members to support multiple QC labs globally.

Be the subject-matter expert for the lab systems during inspections and audits.

Be responsible for administration, maintenance and user management (e.g. create and manage roles, and support user access review request) of lab systems such as Labware LIMS, Waters Empower, ELN and Binocs .

Facilitate and/or initiate enhancements and changes to the lab systems in close collaboration with the vendor.

Conduct training sessions to users to ensure proper use of the laboratory systems.

Regularly monitor the performance of the lab systems, identify bottlenecks, and implement optimizations to improve efficiency and user experience.

Ensure seamless integration in between the lab systems (e.g. LIMS and Empower) and with other business systems (e.g. LIMS with Data Lakes and ERP (SAP) systems) to enhance data flow and business processes.

Manage and ensure proper operation of GxP and non-GxP lab systems by adhering to Astellas global and local procedures and guidelines.

Continue:Role and Responsibilities

Work collaboratively with team members within the subdivision and across other digital and business units

Actively participate in and contribute to various initiatives like process improvements and set up/improve the Scientific IT landscape

Contribute to the ongoing realization of Value from these lab systems through continuous integration and deployment.

Engage in continuous learning and professional development to stay abreast of the latest trends and technologies in the specific area of expertise.

Contribute innovative ideas and approaches to enhance project outcomes and digital capabilities.

Employ analytical and problem-solving skills to overcome project challenges and deliver effective solutions.

Essential Qualifications

Bachelor’s degree in relevant biotech area (e.g. pharmaceutical- and bio technology)

Fluent in written and spoken business English and Spanish.

Minimum of 5+ years demonstrated experience in the scientific IT area, preferably in pharma/biotech environments

Mandatory experience in CDS (Empower), LIMS (Labware) and SDMS lab systems

Knowledge of manufacturing processes, equipment qualification and computer systems validation (CSV) according to GAMP 5 principles is a must.

Strong analytical and problem-solving skills

Ability to work effectively in a team environment

Excellent communication skills, both written and verbal (English (or English/Japanese for JP region)

Agile and adaptable to changing environments and initiative scopes

Demonstrated experience working with business to define Epics/user stories/features, as well as conducting impact analysis

Able to support technical upgrade by conducting impact assessment, addressing any issues, support testing, and document changes per the System Life Cycle (SLC) processes in Astellas.

Maintain CMDB for each of the relevant systems

Continue: Essential Qualifications

Support system deliverables and provide technical and functional feedback during internal and external system audits

Work closely with the internal privacy and security team to assess personal Information requests and act according per the privacy laws applicable to the region.

Maintain and report any issues and communicate effectively to all stakeholders during project/enhancement phase, service disruptions, and during technical upgrades

Lead without authority and be escalation point for any customer issues

Resolve conflicts and provide mediation in service disputes between suppliers and Astellas

Ability to manage critical problem and outage situations under extreme pressure • Experience with vendor management for high value / high impact contracts

Excellent people management skills over technical, service delivery and operational staff

Ensure that business and IT needs are clearly articulated for effective delivery.

Act as system owner for relevant QC systems, responsible for keeping the systems in validated state.

Experience maintaining relationship with suppliers and maintain the relevant budgets

Preferred Qualifications

Agile Champion: Adherence to DevOps principles and a proven track record with CI/CD pipelines for continuous delivery

Preferred knowledge in PL/SQL, Python, Qlik and Databricks

Present technical and/or functional solutions based on the business requirement of the Manufacturing system.

Significant experience in developing and configuring with Empower, LIMS Software and QC Lab Solutions

Benefits

Careers | Astellas

Why Astellas

Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.

Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.

Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.

A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.

Our Organizational Values and Behaviors

Values: Integrity, Innovation and Impact sit at the heart of what we do.

Behaviors: We come together as ‘One Astellas’ , working with courage and a sense of urgency . We are outcome focused and consistently take accountability for our personal contribution.