About this role
Principal Computer System Validation Specialist at Astellas. Location: Westborough, Massachusetts, United States. Role: leading validation, authoring deliverables, managing audits Requirements: Bachelor's degree, 5–8 years computer system validation in pharma/biotech, deep knowledge of GxP/GAMP 5/21 CFR Part 11/Annex 11, experience validating LIMS/MES/QMS/ERP/OSI PI/Empower/SAP/LabWare, strong technical writing and project management. Category: Research and Development (R&D) Seniority: Senior Level Tools: LIMS, MES, QMS, ERP, OSI PI, Empower, SAP, LabWare, GAMP 5, 21 CFR Part 11, EU Annex 11 Certifications: project management, lean six sigma Commitment: Full Time Workplace: Hybrid Languages: English