8+ YOEBachelor's degree in a scientific or technical discipline; 8–10 years in GxP and 4 years leading quality projects. Requires GxP, FDA, EMA, ICH, ISO, QRM, data integrity, and sterile manufacturing expertise.
10+ YOEExtensive experience operating and maintaining clean and plant utility systems in regulated environments, troubleshooting PLC/automation, SAP S4/HANA master data, cGMP compliance, training/coaching staff, and supporting start-up and commissioning.
SAP S4/HANA, PLC, Building Management Systems, Computerized Maintenance Management Systems, AI, word processors, spreadsheets, email