Site Engineering & Reliability Manager – GMP Manufacturing

Novartis; Indianapolis (IN); On-site; USD 114,000 - 212,000; Full time

Job summary

Novartis Indianapolis seeks a Site Engineering Manager to lead process engineering and maintenance in a GMP manufacturing environment, building a high‑performing technical team and guiding capital projects, reliability programs, and asset management.

You will collaborate with Operations, Quality, Automation, and Supply Chain, ensure compliance with FDA Title 21 CFR Part 11 and GAMP5, and travel up to 10% as needed; a strong leadership background is essential.

Qualifications

• Bachelor's degree in Engineering, Computer Science, Automation, or related technical field.
• Minimum 5 years of engineering, maintenance, reliability, process, or equipment experience in regulated manufacturing.
• Minimum 3 years of people leadership in a cGMP environment.

Responsibilities

• Provide strategic and day-to-day leadership for Process Engineering and Maintenance.
• Coach and develop engineers and maintenance staff while remaining engaged in troubleshooting and execution.
• Own site maintenance and asset-management programs, including preventive, predictive, and corrective maintenance.

Skills

People leadership

GMP knowledge

FDA 21 CFR Part 11

Project management

Process engineering

Risk assessment

Education

Bachelor's degree in Engineering, Computer Science, Automation, or related technical field

Job description

Novartis Indianapolis seeks a Site Engineering Manager to lead process engineering and maintenance in a GMP manufacturing environment, building a high‑performing technical team and guiding capital projects, reliability programs, and asset management.

You will collaborate with Operations, Quality, Automation, and Supply Chain, ensure compliance with FDA Title 21 CFR Part 11 and GAMP5, and travel up to 10% as needed; a strong leadership background is essential.