Automation Engineer III - Compounding/CIP/SIP/Utility Distribution
Novartis
Summary
Imagine using your automation expertise to support the systems that enable safe, compliant, and reliable pharmaceutical manufacturing every day. As an Automation Engineer III focused on Compounding, CIP, SIP, and Utility Distribution systems, you'll help ensure critical process automation platforms operate at peak performance while supporting the production of medicines for patients worldwide. Working across Engineering, Manufacturing, and Quality, you'll drive troubleshooting, system improvements, and automation projects that enhance reliability, efficiency, and GMP compliance throughout the manufacturing process.
Job description
Key Responsibilities
- Maintain, troubleshoot, and optimize compounding, CIP, SIP, 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, CIP, SIP, and utility distribution systems.
- Lead automation activities for capital projects, upgrades, and system enhancements.
- Develop URS, FS, DDS, HDS, and SDS documentation 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, SOPs, and system records in alignment with FDA and GMP requirements.
Essential Requirements
- Bachelor's degree in Engineering, Computer Science, or a related technical field.
- Minimum 5 years of experience in pharmaceutical or biopharmaceutical GMP manufacturing operations, or 9 years of equivalent industry experience.
- Hands-on experience programming, troubleshooting, and maintaining DCS platforms, preferably DeltaV.
- Experience supporting compounding, CIP, SIP, utility, PLC, and SCADA/HMI systems in GMP manufacturing.
- Knowledge of automation validation, change controls, and FDA 21 CFR Part 11 requirements.
- Experience with data historian technologies, preferably OSI PI.
- Strong understanding of process instrumentation, utility systems, control system architecture, and industrial communication protocols.
- Excellent communication and collaboration skills with the ability to work across technical and business teams.
Requirements
- Bachelor's degree in Engineering, Computer Science, or a related technical field.
- Minimum 5 years of experience in pharmaceutical or biopharmaceutical GMP manufacturing operations, or 9 years of equivalent industry experience.
- Hands-on experience programming, troubleshooting, and maintaining DCS platforms, preferably DeltaV.
- Experience supporting compounding, CIP, SIP, utility, PLC, and SCADA/HMI systems in GMP manufacturing.
- Knowledge of automation validation, change controls, and FDA 21 CFR Part 11 requirements.
- Experience with data historian technologies, preferably OSI PI.
- Strong understanding of process instrumentation, utility systems, control system architecture, and industrial communication protocols.
- Excellent communication and collaboration skills with the ability to work across technical and business teams.
Benefits
- Health benefits
- Life and disability benefits
- 401(k) with company contribution and match
- Performance-based cash incentive
- Annual equity awards
- Vacation
- Personal days
- Holidays
Company overview
Novartis is a global pharmaceutical company headquartered in Basel, Switzerland, dedicated to reimagining medicine to improve and extend people's lives. As an innovative medicines company, Novartis focuses on developing high-value treatments that address society's greatest disease burdens through technology leadership in research and development. The company operates across five core therapeutic areas: cardiovascular, renal and metabolic diseases; immunology; neuroscience; oncology; and hematology. With a workforce of approximately 75,883 employees worldwide, Novartis reaches nearly 300 million patients across 118 countries. The company leverages advanced technology platforms including targeted protein degradation, cell therapy, gene therapy, radioligand therapy, and xRNA to develop breakthrough treatments. Novartis maintains a strong portfolio of oncology drugs and generics while continuously expanding its pipeline through strategic acquisitions and internal research. The company's commitment extends beyond drug development to ensuring global access to medical innovations through novel access approaches and patient assistance programs.