Global QC Labs Application Engineer - Manufacturing Systems

Global QC Labs Application Engineer - Manufacturing Systems

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.

Purpose & 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.
• 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