Process Engineer II, Indy Isotopes

U469 (FCRS = US469) AAA USA Inc.; Indianapolis (IN); On-site; USD 94,000 - 174,000; Full time

Benefits offered by this job

Health, life and disability benefits

401(k) with company contribution and 2

Generous time off package

Job summary

Novartis seeks a Process Engineer II to support the launch and ongoing success of the Isotopes Manufacturing site in Indianapolis. You will help ensure reliable operation, optimization, and continuous improvement of critical manufacturing systems in a regulated environment.

You will apply engineering expertise to equipment lifecycle management, qualifications, maintenance programs, and process improvements while collaborating with cross-functional teams to drive operational excellence and

Qualifications

• Bachelor's degree in Chemical, Electrical, Mechanical engineering or related field.
• 3+ years in maintenance, automation, engineering, or technical support in pharma/biotech.

Responsibilities

• Support startup and long-term success of the Isotopes site with engineering excellence.
• Maintain equipment inventories to support compliant manufacturing operations.
• Assist with engineering changes including documentation and implementation.
• Execute qualification protocols and support validation of equipment and systems.
• Investigate equipment issues to ensure timely, compliant resolutions.
• Collaborate with cross-functional teams to optimize performance and efficiency.
• Support audits, commissioning activities, and regulated documentation.

Skills

GMP compliance

Project management

Regulatory knowledge

Maintenance planning

Education

Bachelor's degree in Chemical Engineering, Electrical, Mechanical

Tools

Building Management Systems

Computerized Maintenance Management Systems

Microsoft Office

Job description

Job Description Summary

Location: Indianapolis, Indiana
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.

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 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.

Desirable Requirements

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

Salary

The salary for this position is expected to range between $93,800 and $174,200 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.

Salary Range $93,800.00 - $174,200.00

Performance Incentives

Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.

Benefits

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

EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [e-mail] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Additional Information

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