Process Engineer II, Indy Isotopes

Novartis • Indianapolis, IN

1d • $93,800 - $174,200 • Onsite

About The Position

Are you passionate about solving complex engineering challenges in a highly regulated manufacturing environment? As a Process Engineer II, you will play a vital role in supporting the launch and ongoing success of Novartis' new Isotopes Manufacturing site in Indianapolis. You will help ensure reliable operation, optimization, and continuous improvement of critical manufacturing systems that support the production of innovative therapies for patients. Working within a fast-paced environment, you will apply your engineering expertise to equipment lifecycle management, technical investigations, qualifications, maintenance programs, and process improvements while collaborating with cross-functional teams to drive operational excellence, compliance, and performance. This is an exciting opportunity to contribute to a growing site, expand your technical expertise, and help shape the future of advanced pharmaceutical manufacturing.

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 within the pharmaceutical, biotechnology, or related industry.
• Demonstrated project management and problem-solving skills, with the ability to troubleshoot technical and equipment-related issues.
• Strong organizational, planning, and communication skills with the ability to manage multiple priorities.
• Commitment to following GMPs requirements, site procedures, and applicable quality and regulatory standards. (For example: OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.)
• Proficiency with Microsoft Office applications and computerized systems used in regulated manufacturing environments, including Building Management Systems,and Computerized Maintenance Management Systems.
• Ability to climb ladders and lift up to 50 pounds as required.

Nice To Haves

• Experience operating or supporting containment isolator manufacturing systems.
• Training or experience in radiochemistry, radiopharmacy, or radiation safety.

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.

Benefits

• health
• life and disability benefits
• a 401(k) with company contribution and match
• a variety of other benefits
• generous time off package including vacation, personal days, holidays and other leaves

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level