ITOT Engineer: GMP Manufacturing Digital Transformation
Healthcare Businesswomen’s Association
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Job summary
Novartis in Carlsbad is seeking an ITOT Engineer to maintain and optimize ITOT systems in a 24/7 manufacturing environment. You will support installation, commissioning, and ongoing improvements of PLCs, HMIs, EMS, BMS, and PC-based control applications to ensure production continuity and compliance with GMP and 21 CFR Part 11.
This role collaborates with IT and OT teams on cybersecurity, CSV activities, and digital transformation initiatives, including AI, automation, and robotics, and supports
Qualifications
- Bachelor's degree in an engineering/technical discipline.
- 2–3 years of hands-on experience with manufacturing control systems (PLC/DCS).
- Pharma/biotech GMP/regulatory experience preferred.
- Experience with MES and IT/OT integration.
- Strong communication across cross-functional teams.
Responsibilities
- Support ITOT systems including PLCs, HMIs, EMS, BMS, and PC-based control apps.
- Maintain IT/OT infrastructure and coordinate with IT for cybersecurity.
- Support CSV activities and IQ/OQ protocols.
- Contribute to GMP documentation and audits.
- Assist with CAPEX projects and new line commissioning.
- Provide on-call coverage for 24/7 facility.
Skills
Education
Tools
Job description
Novartis in Carlsbad is seeking an ITOT Engineer to maintain and optimize ITOT systems in a 24/7 manufacturing environment. You will support installation, commissioning, and ongoing improvements of PLCs, HMIs, EMS, BMS, and PC-based control applications to ensure production continuity and compliance with GMP and 21 CFR Part 11.
This role collaborates with IT and OT teams on cybersecurity, CSV activities, and digital transformation initiatives, including AI, automation, and robotics, and supports
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