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- ...across PLC/SCADA/DCS, historians, MES/LIMS/QMS/CMMS/ERP, cloud data platforms, and APIs. Embed compliance by design: Apply GAMP5/CSA, CSV deliverables (URS, risk, testing, traceability), and ALCOA+ data integrity; support audits/inspections and CAPAs. Monitor...
- ...take part in projects implementing and/or upgrading computer systems, lifecycle activities, and contribute to global QA alignment on CSV and lifecycle tasks. Furthermore, you will be an important contributor in the continuous development and maintenance of the quality systems...
- ...principles Represent shop-floor needs in system design and validate core manufacturing flows Embed GMP/GxP, QA, validation, and CSV requirements into process design Define manufacturing master data and drive site readiness for cutover and go-live Enable...
- ...basics. Experience in biotech/life sciences or other regulated industries; familiarity with data privacy and, where applicable, GxP/CSV/CSA and 21 CFR Part 11. What’s in it for you Impact at enterprise scale: Your engineering will power analytics and AI across...