Process Engineer II – Isotopes Manufacturing Startup

Healthcare Businesswomen’s Association; Indianapolis (IN); On-site; USD 94,000 - 174,000; Full time

Job summary

Novartis is seeking a Process Engineer II for its Isotopes Manufacturing site in Indianapolis. You will help launch and sustain reliable, compliant manufacturing systems, managing equipment lifecycle, investigations, qualifications, and maintenance programs.

The role focuses on process improvement, cross-functional collaboration, and adherence to GMP and regulatory standards in a fast-paced, highly regulated environment.

Qualifications

• Bachelor’s degree in Chemical, Electrical, or Mechanical Engineering or related field required.
• Minimum 3 years of maintenance, automation, or technical support in pharma/biotech.
• Experience with GMP, regulatory standards, and quality systems.
• Proven project management and problem-solving abilities; strong communication.

Responsibilities

• Support startup and long-term success of the Isotopes site with engineering excellence.
• Maintain equipment inventories and ensure reliable, compliant operations.
• Assist with engineering changes, documentation, and qualification activities.
• Run qualification protocols and support validation of equipment and systems.
• Investigate equipment issues and deviations to ensure timely, compliant resolution.
• Collaborate with cross-functional teams to boost performance and efficiency.
• Support audits, commissioning, and engineering documentation in a regulated setting.

Skills

GMP compliance

Regulatory knowledge

Project management

Troubleshooting

Cross-functional collaboration

MS Office

Education

Bachelor’s degree in Chemical, Electrical, or Mechanical Engineering

Tools

CMMS

Building Management Systems

Job description

Novartis is seeking a Process Engineer II for its Isotopes Manufacturing site in Indianapolis. You will help launch and sustain reliable, compliant manufacturing systems, managing equipment lifecycle, investigations, qualifications, and maintenance programs.

The role focuses on process improvement, cross-functional collaboration, and adherence to GMP and regulatory standards in a fast-paced, highly regulated environment.