Site Engineering Manager, GMP Manufacturing & Reliability

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

Job summary

Novartis is seeking a Site Engineering Manager in Indianapolis to lead Process Engineering and Maintenance within a GMP environment. You will guide capital projects, ensure equipment reliability, and manage cross-functional partnerships to support compliant manufacturing operations.

You will develop technical teams, oversee commissioning/qualification activities, and drive improvements in process capability, safety, and product quality while managing budgets and audits.

Qualifications

• Minimum 5 years of engineering, maintenance, reliability, process, or equipment experience in regulated manufacturing industries.
• 3+ years of people leadership experience.
• Experience with cGMP environments and FDA regulations (21 CFR Part 11, GAMP5).
• Strong communication skills for diverse stakeholders.

Responsibilities

• Provide strategic and day-to-day leadership for Process Engineering and Maintenance.
• Coach and develop engineers and maintenance staff; engage in troubleshooting and recovery.
• Ensure safety, compliance, and asset-management programs; lead maintenance activities.
• Drive reliability strategies to improve performance and reduce downtime.

Skills

Leadership

Regulatory knowledge

Written & verbal communication

Travel readiness

Education

Bachelor's degree in Engineering

Job description

Novartis is seeking a Site Engineering Manager in Indianapolis to lead Process Engineering and Maintenance within a GMP environment. You will guide capital projects, ensure equipment reliability, and manage cross-functional partnerships to support compliant manufacturing operations.

You will develop technical teams, oversee commissioning/qualification activities, and drive improvements in process capability, safety, and product quality while managing budgets and audits.