Senior Automation Engineer Onsite Drug Product

Novartis Farmacéutica; Durham (NC); On-site; USD 109,000 - 202,000; Full time

Benefits offered by this job

Health and disability benefits

401(k) with company match

On-site in Durham

Job summary

Novartis Farmacéutica seeks a Senior Automation Engineer to lead automation design and serve as SME for a GMP manufacturing facility in Durham, NC. The role requires overseeing automation aspects of projects, integrating 3rd party equipment, and ensuring compliance with FDA/21 CFR part 11.

Responsibilities include lifecycle documentation, qualification planning with C&Q, and supporting 24x7 operations. On-site only, with up to 10% travel and a strong emphasis on initiative and leadership.

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 and technical writing ability.
• Experience programming, troubleshooting, and maintaining site automation systems (DCS, BMS, PLC, SCADA, historian, infrastructure).
• Experience applying S88 in automated environments and development of control system standards.

Responsibilities

• Design, configure, install and maintain automation software and hardware for equipment and processes.
• Lead small teams and manage automation contractors.
• Coordinate with internal partners on priorities, timelines and information sharing.
• Develop and approve lifecycle documentation (URS, FS, DDS/HDS/SDS).
• Support GMP manufacturing transitions of new products and 24x7 site operations.

Skills

Leadership

Communication

Project management

GMP experience

Problem solving

Education

B.S. in Engineering / Computer Science / related field

Tools

DCS

BMS

PLC

SCADA

Historian

Instrumentation

Job description

Novartis Farmacéutica seeks a Senior Automation Engineer to lead automation design and serve as SME for a GMP manufacturing facility in Durham, NC. The role requires overseeing automation aspects of projects, integrating 3rd party equipment, and ensuring compliance with FDA/21 CFR part 11.

Responsibilities include lifecycle documentation, qualification planning with C&Q, and supporting 24x7 operations. On-site only, with up to 10% travel and a strong emphasis on initiative and leadership.