Global QC labs Application Engineer - Manufacturing Systems

Astellas - (Contractor) - Sanford, NC

Full-time - Mid Level

Sanford, NC

10,001+ employees

About the position

The Global QC Labs Application Engineer at Astellas is a Subject Matter Expert responsible for the administration, maintenance, and enhancement of laboratory systems within the Manufacturing QC labs. This role focuses on ensuring the proper operation of GxP and non-GxP systems, providing technical support, and facilitating improvements in laboratory processes. The engineer will work collaboratively with global QC labs, manage user access, conduct training, and ensure seamless integration of lab systems with other business systems.

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 of lab systems such as Labware LIMS, Waters Empower and NuGenesis, Shimadzu LabSolutions, 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 and with other business 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

Requirements

• Experience with laboratory systems such as Chromatography Data Systems (CDS), Scientific Data Management Systems (SDMS), Laboratory Information Management Systems (LIMS), and Electronic Lab Notebook (ELN)
• Strong technical support skills and experience in user management
• Ability to conduct training sessions and provide user support
• Experience in managing GxP and non-GxP systems
• Strong analytical and problem-solving skills
• Ability to work collaboratively in a global team environment

Nice-to-haves

• Experience with specific lab systems like Labware LIMS, Waters Empower, and NuGenesis
• Knowledge of integration with ERP systems like SAP
• Familiarity with continuous integration and deployment practices
• Experience in process improvement initiatives

Benefits

• Competitive salary
• Health insurance
• 401k plan
• Paid time off
• Professional development opportunities