Process Engineer II, Indy Isotopes
Novartis
August 13, 2026
On-site
Indianapolis, IN
Operations
Key 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.
Essential Requirements:
- 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 in pharmaceutical/biotechnology (or related) industry.
- Demonstrated project management and problem-solving skills; ability to troubleshoot technical/equipment issues.
- Strong organizational, planning, and communication skills; ability to manage multiple priorities.
- Commitment to GMPs and applicable quality/regulatory standards (e.g., OSHA, DEA, FDA, EMEA, ANVISA, HS&E).
- Proficiency with Microsoft Office and computerized systems used in regulated manufacturing (e.g., Building Management Systems, Computerized Maintenance Management Systems).
- Ability to climb ladders and lift up to 50 pounds as required.
Desirable Requirements:
- Experience operating or supporting containment isolator manufacturing systems.
- Training or experience in radiochemistry, radiopharmacy, or radiation safety.
- 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.
Essential Requirements:
- 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 in pharmaceutical/biotechnology (or related) industry.
- Demonstrated project management and problem-solving skills; ability to troubleshoot technical/equipment issues.
- Strong organizational, planning, and communication skills; ability to manage multiple priorities.
- Commitment to GMPs and applicable quality/regulatory standards (e.g., OSHA, DEA, FDA, EMEA, ANVISA, HS&E).
- Proficiency with Microsoft Office and computerized systems used in regulated manufacturing (e.g., Building Management Systems, Computerized Maintenance Management Systems).
- Ability to climb ladders and lift up to 50 pounds as required.
Desirable Requirements:
- Experience operating or supporting containment isolator manufacturing systems.
- Training or experience in radiochemistry, radiopharmacy, or radiation safety.