Process Engineer II - Isotopes Manufacturing, GMP Ops

Novartis Group Companies; Indianapolis (IN); On-site; USD 94,000 - 174,000; Full time

Job summary

Novartis Group of Companies is seeking a Process Engineer II to support the startup and ongoing success of the Isotopes Manufacturing site in Indianapolis, IN. You will help ensure reliable operation, optimization, and continuous improvement of critical manufacturing systems in a highly regulated environment.

Responsibilities include equipment lifecycle management, qualifications, maintenance programs, and process improvements, while collaborating with cross-functional teams to drive compliance,

Qualifications

• Bachelor's degree in Chemical Engineering, Electrical Engineering, Mechanical Engineering, or a related technical field.
• Minimum 3 years of maintenance, automation, engineering, or equivalent technical support experience within pharma/biotech or related industry.
• Demonstrated project management and problem-solving skills.
• Strong organizational, planning, and communication skills with the ability to manage multiple priorities.
• Commitment to following GMPs, site procedures, and applicable quality/regulatory standards (OSHA, DEA, FDA, etc.).
• Proficiency with Microsoft Office and computerized systems used in regulated manufacturing environments, including Building Management Systems and CMMS.

Responsibilities

• Support the startup and long-term success of the new Isotopes Manufacturing site through engineering excellence.
• Maintain equipment and instrument inventories to support reliable and compliant manufacturing operations.
• Assist with engineering change activities, including change requests, implementation activities, and documentation support.
• Execute qualification protocols and support validation activities for manufacturing equipment and systems.
• Support investigations of equipment issues, deviations, and technical challenges to ensure timely resolution and compliance.
• Partner with cross-functional teams to optimize equipment performance, reliability, and process efficiency.
• Support audits, commissioning activities, and engineering documentation within a regulated manufacturing environment.

Skills

Project management

Problem-solving

Strong communication

Education

Bachelor's degree in Chemical Engineering or related field

Tools

Building Management Systems

Computerized Maintenance Management Systems

Job description

Novartis Group of Companies is seeking a Process Engineer II to support the startup and ongoing success of the Isotopes Manufacturing site in Indianapolis, IN. You will help ensure reliable operation, optimization, and continuous improvement of critical manufacturing systems in a highly regulated environment.

Responsibilities include equipment lifecycle management, qualifications, maintenance programs, and process improvements, while collaborating with cross-functional teams to drive compliance,