Senior Site Engineering Lead – GMP Manufacturing

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

Benefits offered by this job

Health, Life & Disability benefits

401(k) with company match

Paid time off

Job summary

Novartis Group of Companies in Indianapolis, IN, seeks a Site Engineering Manager to lead process engineering and maintenance in a regulated GMP environment. You will drive reliability initiatives, capital projects, and asset-management programs while partnering across Quality, Automation, Supply Chain and Operations to ensure safe, compliant manufacturing operations.

You will mentor engineers, lead investigations and change controls, and contribute to audits and regulatory readiness.

Qualifications

• Bachelor's degree in Engineering or related field.
• Minimum 5 years in engineering, maintenance, reliability or related in regulated manufacturing.
• 3+ years leading technical teams in a cGMP environment.
• Proficient knowledge of FDA regulations and GMP systems.
• Willingness to travel up to 10%.

Responsibilities

• Provide strategic and day-to-day leadership for Process Engineering and Maintenance.
• Coach and develop engineers and maintenance staff while remaining hands-on when needed.
• Ensure equipment safety, compliance, qualification, and reliability; manage maintenance programs.
• Drive reliability strategies to reduce downtime and improve process performance.
• Oversee commissioning, qualification, validation, and lifecycle documentation.

Skills

Leadership

Regulatory compliance

Process engineering

Maintenance management

FDA regulations

Education

Bachelor's degree in Engineering

Job description

Novartis Group of Companies in Indianapolis, IN, seeks a Site Engineering Manager to lead process engineering and maintenance in a regulated GMP environment. You will drive reliability initiatives, capital projects, and asset-management programs while partnering across Quality, Automation, Supply Chain and Operations to ensure safe, compliant manufacturing operations.

You will mentor engineers, lead investigations and change controls, and contribute to audits and regulatory readiness.