GMP IT/OT Engineer - 24/7 Manufacturing Systems
Novartis
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Zusammenfassung
Novartis in Carlsbad seeks an ITOT Engineer to maintain and optimize ITOT systems across a 24/7 manufacturing site. You will troubleshoot PLCs, HMIs, EMS, BMS and PC-based control apps to ensure continuous production and regulatory compliance.
The role includes supporting IT/OT infrastructure, CSV activities, CAPEX project participation, and driving digital transformation through AI and automation initiatives, with on-call coverage.
Qualifikationen
- Bachelor's degree in Engineering or related technical discipline.
- 2-3 years hands-on experience with manufacturing control systems (PLC/DCS).
- Experience in pharmaceutical/biotech industries with GMP exposure.
- Familiarity with MES, PLCs (Allen-Bradley, Siemens) and EMS/BMS preferred.
Aufgaben
- Support ITOT systems including PLCs, HMIs, EMS, BMS to maintain reliability of manufacturing and facility operations.
- Assist with IT/OT infrastructure (servers, VMs, network devices, application hosting, backup and disaster recovery) and collaborate with IT on cybersecurity.
- Support CSV activities, including IQ and OQ protocol generation/execution for ITOT systems.
- Assist with GMP documentation (deviations, change controls, CAPAs, validation protocols, risk assessments) and audits.
- Support CAPEX projects to install, qualify, and commission new production lines; coordinate ITOT scope.
Kenntnisse
Ausbildung
Jobbeschreibung
Novartis in Carlsbad seeks an ITOT Engineer to maintain and optimize ITOT systems across a 24/7 manufacturing site. You will troubleshoot PLCs, HMIs, EMS, BMS and PC-based control apps to ensure continuous production and regulatory compliance.
The role includes supporting IT/OT infrastructure, CSV activities, CAPEX project participation, and driving digital transformation through AI and automation initiatives, with on-call coverage.
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