Jobs → Engineering → Global QC Labs Application Engineer

About the Role We are seeking a Global QC Labs Application Engineer to join Astellas. This role involves supporting technical upgrades, maintaining systems, and ensuring compliance with validation processes in a biotech environment. Key Responsibilities • Support technical upgrades by conducting impact assessments, addressing issues, supporting testing, and documenting changes per System Life Cycle (SLC) processes • Maintain Configuration Management Database (CMDB) for relevant systems • Provide technical and functional feedback during internal and external system audits • Work closely with privacy and security teams to assess personal information requests • Lead without authority and act as an escalation point for customer issues • Resolve conflicts and mediate service disputes between suppliers and Astellas • Maintain relationships with suppliers and manage relevant budgets Requirements • Bachelor’s degree in biotech or pharmaceutical technology • Minimum of 5+ years of experience in scientific IT, preferably in pharma/biotech • Mandatory experience in CDS (Empower), LIMS (Labware), and SDMS lab systems • Knowledge of manufacturing processes, equipment qualification, and CSV according to GAMP 5 principles • Strong analytical and problem-solving skills • Excellent communication skills in English (or English/Japanese for JP region) • Experience with vendor management for high-value contracts • Agile and adaptable to changing environments Benefits • Hybrid work policy: 2 days office work per week (mandatory) • Opportunity to work with a leading biotech company