Senior Engineer, Automation
Not Disclosed•Full-TimeOn-site
location_on577, Mallard Avenue, Durham, Durham County, North Carolina, 27701, United States
About the Role
The Senior Automation Engineer serves as a technical subject matter expert and design team leader within the AD Process Automation group at Novartis. Based in Durham, NC, this on-site role is critical to the operation of our Aseptic Drug Product facility. You will bridge the gap between engineering design and GMP manufacturing, ensuring that automation systems are robust, compliant, and capable of supporting complex drug production processes.
This position exists to drive operational excellence and continuous improvement within a highly regulated environment. You will lead the design, commissioning, and qualification of new automation equipment while managing the integration of third-party systems into our standard plant infrastructure. The role requires a balance of deep technical expertise in control systems and strong leadership skills to guide projects, manage contractors, and collaborate with internal business partners on priorities and timelines.
Day in the Life
Your work will span the entire lifecycle of automation assets. You will develop and approve critical documentation, including User Requirements (URS), Functional Specifications (FS), and Detail Design Specifications, ensuring alignment with S88 methodology and FDA regulations (21 CFR Part 11). A significant portion of your time will be dedicated to solving technical issues impacting production, supporting 24x7 site operations through rotating on-call responsibilities, and leading investigations into non-conformances.
You will also partner closely with the Quality team to maintain a compliant manufacturing environment, participating in regulatory audits as the automation SME. From preparing scopes of work for large projects to executing complex change controls, you will ensure smooth transitions from process development into GMP manufacturing while managing project timelines and resources effectively.
Work location
Work model: On-site
577, Mallard Avenue, Durham, Durham County, North Carolina, 27701, United States
Durham, North Carolina
Key Responsibilities
- check_circleDesign and commission automation aspects of new equipment to meet Novartis standards
- check_circleLead small teams and manage automation contractors to complete projects within timelines
- check_circlePartner with Quality to ensure a compliant manufacturing environment and support regulatory audits
- check_circleLead new product implementation processes to ensure smooth transition from development to GMP manufacturing
- check_circleSupport 24x7 site-based operations including rotating on-call responsibilities
- check_circleOversee automation project integration with DCS, BMS, Historian, and infrastructure systems
- check_circleDevelop and maintain lifecycle documentation including URS, FS, and design specifications
- check_circleInvestigate and resolve non-conformances and technical issues impacting production systems
- check_circleDevelop and maintain procedures to ensure GMP compliance and adherence to CFR regulations
Requirements
- verifiedB.S. degree in Engineering, Computer Science, or related technical field
- verified8 years work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations (or 12 years equivalent)
- verifiedExperience programming, troubleshooting, and maintaining DCS, BMS, PLC, SCADA, historian, infrastructure, and industrial protocols
- verifiedExperience in system level qualification testing
- verifiedProven experience applying S88 in an automated environment
- verifiedExperience in field wiring practices, panel design, control systems start-up, and instrumentation
- verifiedExperience writing and executing complex change controls
- verifiedIn-depth knowledge of FDA regulations particularly 21 CFR part 11 and GMP systems
- verifiedStrong project management skill set
Nice to Have
Experience with API (Application Programming Interface), Back-End Development, Java (Programming Language), Reactjs, Kubernetes, Mathematical Optimization, Knowledge of CAPA, and General HSE Knowledge including GDP.
Benefits & Perks
check_circleHealth, life, and disability benefitscheck_circle401(k) with company contribution and matchcheck_circlePerformance-based cash incentivecheck_circleAnnual equity awards eligibilityVacation, personal days, holidays, and other leaves
Similar Job Opportunities
Skills, education and keywords
Skills: DCS, BMS, PLC, Scada, S88, 21 CFR Part 11, GMP, Api, Java, Kubernetes.
Education: B.S. degree in Engineering, Computer Science, or related technical field required.
Frequently asked questions about Senior Engineer, Automation at Novartis
What does a Senior Engineer, Automation at Novartis do?expand_more
In this Senior Engineer, Automation at Novartis role, you will design and commission automation aspects of new equipment to meet novartis standards; lead small teams and manage automation contractors to complete projects within timelines; partner with quality to ensure a compliant manufacturing environment and support regulatory audits; and lead new product implementation processes to ensure smooth transition from development to gmp manufacturing.
What are the requirements for this Senior Engineer, Automation role?expand_more
To qualify for the Senior Engineer, Automation at Novartis position, applicants should have: B.S. degree in Engineering, Computer Science, or related technical field; 8 years work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations (or 12 years equivalent); Experience programming, troubleshooting, and maintaining DCS, BMS, PLC, SCADA, historian, infrastructure, and industrial protocols; Experience in system level qualification testing; Proven experience applying S88 in an automated environment; and Experience in field wiring practices, panel design, control systems start-up, and instrumentation.
Where is the Senior Engineer, Automation role at Novartis located?expand_more
Senior Engineer, Automation at Novartis is based in 577, Mallard Avenue, Durham, Durham County, North Carolina, 27701, United States. This is a on-site role.
Is this Senior Engineer, Automation job remote, hybrid, or on-site?expand_more
Novartis has listed this Senior Engineer, Automation role as on-site.
How much experience is required for this Senior Engineer, Automation role?expand_more
Senior Engineer, Automation at Novartis typically requires 8+ years of relevant experience at the senior level.
What skills do you need for the Senior Engineer, Automation role at Novartis?expand_more
Key skills for Senior Engineer, Automation at Novartis include DCS; BMS; PLC; Scada; S88; 21 CFR Part 11; GMP; and Api.
What education is required for Senior Engineer, Automation at Novartis?expand_more
Educational requirements for this role: B.S. degree in Engineering, Computer Science, or related technical field required.
What category does the Senior Engineer, Automation role belong to?expand_more
Senior Engineer, Automation at Novartis is part of the engineering job category on Recrutus.