IT/OT Automation Engineer – 24/7 GMP Ops

Novartis Group Companies; Carlsbad (CA); On-site; USD 99,000 - 183,000; Full time

Benefits offered by this job

Health benefits

401(k) plan

Paid time off

Job summary

Novartis Group of Companies in Carlsbad, CA, seeks an ITOT Engineer to maintain, troubleshoot, and support ITOT systems for a 24/7 manufacturing facility. You will install, commission, and optimize ITOT systems, ensuring GMP compliance and quality standards across operations.

You will contribute to digital transformation, AI, automation, and robotics projects, while supporting CAPEX activities to commission new production lines.

Qualifications

• Bachelor's degree in Engineering or related field.
• 2–3 years with PLC/DCS and IT/OT infra supporting OT technologies.
• 2–3 years pharma/biotech GMP and regulatory knowledge.
• Experience with PLCs (Allen-Bradley, Siemens) or DCS and MES.
• Familiarity with EMS/BMS and industrial networking.
• Understanding of GMP/GxP, 21 CFR Part 11, CSV/CSA.
• Strong cross-functional communication and teamwork.

Responsibilities

• ITOT Systems Support: support, troubleshoot, and enhance ITOT systems including PLCs, HMIs, EMS, BMS, and PC-based control apps.
• IT/OT Infrastructure Support: assist with servers, VMs, network devices, backups, and cybersecurity coordination.
• CSV Activities: support IQ and OQ protocols to ensure regulatory compliance.
• Compliance & Quality Documentation: assist GMP docs, deviations, CAPAs, validation, risk assessments.
• Investigation & Continuous Improvement: assist root cause analysis and system performance improvements.
• Project Support: support ITOT/digital transformation projects from concept to commissioning, including FAT/SAT.
• Digital Transformation: drive AI initiatives, automation, robotics with cross-functional teams.
• CAPEX & New Line Commissioning: coordinate ITOT scope for new lines with engineering and vendors.
• Essential On-Call Coverage: provide on-call support for 24/7 operations.

Skills

PLC/DCS

MES

GMP

English

Industrial networking

Education

Bachelor's degree

Tools

EMS

BMS

PI Historian

SCADA

VMs

Job description

Novartis Group of Companies in Carlsbad, CA, seeks an ITOT Engineer to maintain, troubleshoot, and support ITOT systems for a 24/7 manufacturing facility. You will install, commission, and optimize ITOT systems, ensuring GMP compliance and quality standards across operations.

You will contribute to digital transformation, AI, automation, and robotics projects, while supporting CAPEX activities to commission new production lines.