Senior Automation Engineer – Packaging (Onsite)

Novartis; Durham (NC); On-site; USD 124,000 - 186,000; Full time

Benefits offered by this job

Benefits Package Offered

Job summary

Novartis in Durham, NC is seeking a Senior Automation Engineer (Packaging and Sterilization) to lead automation design and act as a subject matter expert for the manufacturing facility. You will maintain, troubleshoot, and modify GMP and non-GMP control systems, including plant-wide DCS, BMS/EMS, MES and other local controls.

The role requires strong project management, experience with DeltaV, Rockwell, OSI PI, and SQL queries, plus knowledge of 21 CFR Part 11.

Qualifications

• B.S. degree in Engineering, Computer Science, or related technical field.
• 8 years work experience in pharmaceutical or biopharmaceutical GMP manufacturing operations, or 12 years equivalent.
• Excellent oral and written communication skills.
• Experience with DCS, SCADA/HMI, and PLC/BMS systems ( DeltaV, Rockwell, Allen Bradley ).
• Experience with OSI PI data historian.
• Experience in system validation testing and qualification plans with C&Q.
• Knowledge of S88 principles and GMP regulatory expectations.
• Experience with data concentration, batch reporting, and data retention.
• Ability to write and execute change controls.
• Up to 10% travel may be required.

Responsibilities

• Provide design, configuration, installation, and maintenance of automation software and hardware.
• Lead automation aspects of projects including integration of 3rd party equipment to DCS and BMS systems.
• Develop project objectives with user requirements and business plans.
• Establish equipment specifications and standard documentation (URS, FS, DDS).
• Drive continuous improvement and operational excellence.
• Support 24x7 site operations and on-call responsibilities.
• Create and revise SOPs to ensure compliance.

Skills

Automation design

DCS

BMS/EMS

MES

Data analysis

Technical writing

Project management

CFR/21 CFR Part 11

Education

B.S. in Engineering, Computer Science, or related field

Tools

DeltaV

Rockwell FactoryTalk View SE

Allen Bradley CompactLogix/ControlLogix

OSI PI

MS SQL

Job description

Novartis in Durham, NC is seeking a Senior Automation Engineer (Packaging and Sterilization) to lead automation design and act as a subject matter expert for the manufacturing facility. You will maintain, troubleshoot, and modify GMP and non-GMP control systems, including plant-wide DCS, BMS/EMS, MES and other local controls.

The role requires strong project management, experience with DeltaV, Rockwell, OSI PI, and SQL queries, plus knowledge of 21 CFR Part 11.