ITOT Engineer: GMP PLC/DCS & Automation

Novartis; Carlsbad (NM); On-site; USD 99,000 - 183,000; Full time

Job summary

Novartis in Carlsbad is seeking an ITOT Engineer to maintain and support ITOT systems for a 24/7 manufacturing facility. You will engage in installation, commissioning, and optimization of ITOT equipment, ensuring safety, regulatory, and quality standards while supporting digital transformation initiatives.

The role covers IT/OT infrastructure, CSV activities, CAPEX project support, and on-call coverage to minimize downtime and sustain continuous production. Fluency in English is required.

Qualifications

• Must have a Bachelor's degree in engineering or related field.
• 2–3 years hands-on experience with PLC/DCS in manufacturing OT environments.
• 2–3 years in pharma/biotech with GMP/regulatory understanding.
• Proficient with PLC/DCS and MES systems.
• Experience with EMS/BMS and industrial networking.
• Knowledge of GMP/GxP, 21 CFR Part 11, and CSV/CSA methodologies.
• Familiar with Change Control, CAPA, and root-cause analysis.
• Strong communication across teams; English fluency.

Responsibilities

• ITOT Systems Support: troubleshoot and enhance PLCs, HMIs, EMS, BMS and PC-based controls.
• IT/OT Infrastructure Support: assist server, VM, network, backup and cybersecurity needs.
• CSV Activities: support IQ/OQ protocols to meet regulatory requirements.
• Compliance & Quality Documentation: support GMP deviations, change controls, CAPAs, validations.
• Investigation & Continuous Improvement: assist root cause analysis and performance improvements.
• Project Support: assist ITOT/digital projects from concept to commissioning.
• Digital Transformation: support AI, automation, and robotics initiatives.
• CAPEX & New Line Commissioning: coordinate ITOT scope for new lines.
• On-Call Coverage: provide 24/7 on-call support to minimize downtime.

Skills

PLC/DCS experience

GMP awareness

Cross-functional collaboration

English fluency

Education

Bachelors in Engineering (Automation/Electrical/Computer)

Tools

Allen-Bradley

Siemens

MES

PI Historians

EMS/BMS

Job description

Novartis in Carlsbad is seeking an ITOT Engineer to maintain and support ITOT systems for a 24/7 manufacturing facility. You will engage in installation, commissioning, and optimization of ITOT equipment, ensuring safety, regulatory, and quality standards while supporting digital transformation initiatives.

The role covers IT/OT infrastructure, CSV activities, CAPEX project support, and on-call coverage to minimize downtime and sustain continuous production. Fluency in English is required.