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

Novartis; Durham (NC); On-site; USD 99,000 - 183,000; Full time

Job summary

Novartis in Durham, NC is seeking an Automation Engineer III focused on compounding, CIP, SIP, and utility distribution to maintain and optimize GMP manufacturing automation. You will troubleshoot, implement control strategies, and drive improvements across Engineering, Manufacturing and Quality teams.

Required: Bachelor's in Engineering or related field and 5+ years in pharma GMP; hands-on DeltaV DCS experience; knowledge of FDA 21 CFR Part 11; on-site role in Durham.

Qualifications

• Bachelor's degree in Engineering, Computer Science, or a related technical field.
• Minimum 5 years of pharma GMP manufacturing experience or 9 years equivalent 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 cross-functional teams.

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.

Skills

DCS platforms (DeltaV)

GMP manufacturing systems

Automation validation & 21 CFR Part 11

OSI PI historian

Process instrumentation & control

Cross-functional collaboration

Education

Bachelor's degree in Engineering/related field

Tools

DeltaV

OSI PI

PLC/SCADA/HMI tools

Job description

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.

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.
About The Role
Location:

• This position will be located in Durham, NC and will be an onsite role.
• Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
  

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.
  

Novartis Compensation And Benefit Summary
The salary for this position is expected to range between $98,700 and $183,300 annually
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.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
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EEO Statement
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
Accessibility & Reasonable Accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.