Hiring: Global QC Labs Application Engineer - Manufacturing Systems Company: Astellas Pharma Location: Sanford, NC Job Posted Time: 2026-09-03 10:24:03 Employment Type: Remote Target Skills & Keywords : Agile, CI/CD, Databricks, PL/SQL, Python, User Experience About the job Experience: •5+ years demonstrated experience in the scientific IT area, preferably in pharma/biotech environments Required Skills: •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. Qualifications: •Bachelor’s degree in relevant biotech area (e.g. pharmaceutical- and bio technology) •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 •Demonstrated capacity 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. Compensation: •$125,090 - $178,700 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!