Job Description SummaryLocation: Indianapolis, 5 days/week onsite
Internal job title: ITOT Engineer
About the Role:
The ITOT Engineer will join the ITOT team and 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 DescriptionKey Responsibilities: - ITOT Systems Support: Support, troubleshoot, and enhance ITOT systems across Manufacturing, Laboratory and Facility applications to maintain reliability of operations: PLCs, HMIs, EMS, BMS, and PC-based control systems; Vertical integration of Data Historians to shop floor systems as well as enterprise systems (MES, SAP etc.); Robotics, Vision System, Industrial Printers.
- IT/OT Infrastructure Support: Assist with maintaining IT/OT infrastructure (servers, virtual machines, network devices, application hosting, backup and disaster recovery, user access and time synchronization), 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.
- 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.
- Compliance & Quality Documentation: Support authoring and review of GMP documentation including deviations, change controls, CAPAs, validation protocols, risk assessments, periodic reviews, SOPs etc. in alignment with 21 CFR Part 11 and GxP requirements.
- Investigation & Continuous Improvement: Support technical investigations into system failures and deviations, lead 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 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.
- 2-3 years of experience as ITOT engineer in a manufacturing site.
- 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.
- Excellent communication skills with ability to coordinate across multidisciplinary teams and vendors, and fluency in English.
Desirable requirements:- Experience in the pharmaceutical or biotechnology industry with a solid understanding of Good Manufacturing Practices (GMP) and regulatory compliance is highly desirable.
The salary for this position is expected to range between $98,700 and $183,300 per year.
The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.
Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
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hereSalary Range$98,700.00 - $183,300.00
Skills DesiredBusiness Continuity, Change Controls, Cost Management, Data Analytics, Emotional Resilience, Engineering Concepts, Good Documentation Practices, Health, Safety, and Environment (HSE) Policy, Manufacturing Processes, Operational Excellence, Quality Compliance, Risk Management, Tool Knowledge, Total Productive Maintenance (TPM)
