ITOT Engineer

Novartis; Lavamünd; Vor Ort; EUR 65.000 - 90.000; Vollzeit

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

English fluency

ITOT systems

PLC/DCS knowledge

GMP awareness

Ausbildung

Bachelor's degree in Engineering or related field

Jobbeschreibung

Job Description Summary

Location: Carlsbad

Internal job title: ITOT Engineer

About the Role:

The ITOT Engineer will be responsible for maintaining, troubleshooting, and supporting ITOT systems to ensure smooth and reliable operation of a 24/7 manufacturing facility. This role supports the installation, commissioning, and ongoing optimization of ITOT systems and equipment, ensuring compliance with safety, regulatory, and quality standards, and provides technical support to minimize downtime and maintain continuous production. The role also contributes to digital transformation efforts within manufacturing operations, supporting initiatives such as AI, process automation, and robotics, and supports CAPEX projects to commission new production lines.

Job Description

Key Responsibilities:

• ITOT Systems Support: Support, troubleshoot, and enhance ITOT systems including PLCs, HMIs, EMS, BMS, and PC-based control applications to maintain reliability of manufacturing and facility operations. Manage user access, account administration, and periodic reviews.
• IT/OT Infrastructure Support: Assist with maintaining IT/OT infrastructure (servers, virtual machines, network devices, application hosting, backup and disaster recovery), coordinating with IT teams on cybersecurity and system integrity.
• CSV Activities: Support Computer System Validation (CSV) activities, including generation and execution of Installation Qualification (IQ) and Operational Qualification (OQ) protocols, to ensure ITOT systems meet regulatory and operational requirements.
• Compliance & Quality Documentation: Support authoring and review of GMP documentation including deviations, change controls, CAPAs, validation protocols, and risk assessments, in alignment with 21 CFR Part 11 and GxP requirements. Participate in audits and inspections by regulatory authorities and internal quality organizations.
• Investigation & Continuous Improvement: Support technical investigations into system failures and deviations, assist with root cause analysis, and contribute to initiatives that improve system performance and efficiency.
• Project Support: Support ITOT and digital transformation projects from concept through commissioning, including FAT/SAT activities, ensuring alignment with GMP, safety, and engineering standards.
• Digital Transformation: Support digital transformation initiatives within manufacturing operations, including driving AI initiatives, process automation, and robotics projects, in collaboration with cross-functional teams.
• CAPEX & New Line Commissioning: Support CAPEX projects to install, qualify, and commission new production lines, coordinating ITOT scope with engineering, project management, and vendor teams.
• Essential On-Call Coverage: Provide on-call support on a rotation basis to support the 24/7 manufacturing facility, promptly addressing ITOT system issues to minimize downtime and maintain continuous production.

Requirements:

• Education: Bachelor's degree in Engineering, Automation Engineering, Electrical Engineering, Computer Engineering, Computer Science, or a related technical discipline.
• Experience: 2-3 years of hands-on experience with manufacturing control systems such as PLC or DCS, with familiarity setting up IT infrastructure to support OT technologies such as PLCs, DCS, MES, and PI Historians.
• Industry Knowledge: 2-3 years of experience in the pharmaceutical or biotechnology industry with a solid understanding of Good Manufacturing Practices (GMP) and regulatory compliance.
• Proficiency with PLCs (e.g., Allen-Bradley, Siemens) or Distributed Control Systems (DCS), and familiarity with Manufacturing Execution Systems (MES).
• Working knowledge of EMS/BMS platforms and industrial networking.
• Understanding of GMP/GxP regulations, 21 CFR Part 11, and CSV/CSA methodologies, including IQ/OQ protocol generation and execution.
• Familiarity with Change Control, CAPA processes, and root cause analysis.
• Effective communication skills with ability to coordinate across multidisciplinary teams and vendors. Fluency in English.

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Why Novartis?

Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. With our people we drive outcomes every day. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

Accessibility and accommodation:

Novartis is committed to working with and providing reasonab