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Novartis

Global pharmaceutical company delivering science-based innovations

Automation Engineer 3 - Compounding/CIP/SIP/Utility Distribution

Controls & Automation EngineeringConfirmed live in the last 24 hours
Full-timeDurham, NC, USAIn-person

About the Job

Requirements

  • A bachelor's degree in Engineering, Computer Science, or a related technical field is required.
  • At least 5 years of experience in pharmaceutical or biopharmaceutical GMP manufacturing operations, or 9 years of equivalent industry experience, is required.
  • Hands-on experience programming, troubleshooting, and maintaining distributed control system platforms, preferably DeltaV, is required.
  • Experience supporting compounding, clean-in-place, steam-in-place, utility, programmable logic controller, and supervisory control and data acquisition/human-machine interface systems in GMP manufacturing is required.
  • Knowledge of automation validation, change controls, and FDA 21 CFR Part 11 requirements is required.
  • Experience with data historian technologies, preferably OSI PI, is required.
  • A strong understanding of process instrumentation, utility systems, control system architecture, and industrial communication protocols is required.
  • Excellent communication and collaboration skills to work across technical and business teams are required.

Responsibilities

  • Maintain, troubleshoot, and optimize compounding, clean-in-place, steam-in-place, utility distribution, and manufacturing automation systems.
  • Support design, configuration, installation, and lifecycle management of automation hardware and software.
  • Support automation and control strategies for compounding, clean-in-place, steam-in-place, and utility distribution systems.
  • Lead automation activities for capital projects, upgrades, and system enhancements.
  • Develop user requirements specifications, functional specifications, detailed design specifications, hardware design specifications, and software design specifications for automation solutions.
  • Execute and support change controls, validation activities, and regulatory compliance initiatives.
  • Partner with Manufacturing and Quality teams to resolve complex production issues.
  • Support GMP manufacturing operations through on-call and operational support activities.
  • Drive continuous improvement projects that enhance reliability, compliance, and operational efficiency.
  • Maintain automation procedures, standard operating procedures, and system records in alignment with FDA and GMP requirements.

About the Company

Novartis

Global pharmaceutical company delivering science-based innovations

Novartis is a global pharmaceutical company that uses science-based innovations to develop treatments and improve patient outcomes worldwide. Its products are medicines developed through research and development to address various diseases, aiming to reach nearly 1 billion people. The company differentiates itself by large-scale investment in R&D, a global presence with a diverse workforce, and a clear mission to Reimagine Medicine, focusing on meeting the changing needs of patients. Its goal is to improve quality of life and extend life expectancy by delivering meaningful therapies through its research and development efforts.

Company size
10,001+
Company stage
IPO
Headquarters
Basel, Switzerland
Founded
1970

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