Process Engineer II, Indy Isotopes

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.

Job Description

• 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.

• Bachelors 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 Systemsand Computerized Maintenance Management Systems.
• Ability to climb ladders and lift up to 50 pounds as required.

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

The salary for this position is expected to range between $93800 and $174200 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. Your compensation will include a performance-based cash incentive and depending on the level of the role eligibility to be considered for annual equity -based eligible employees will receive a comprehensive benefits package that includes health life and disability benefits a 401(k) with company contribution and match and a variety of other addition employees are eligible for a generous time off package including vacation personal days holidays and other leaves.

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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 or call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

$93800.00 - $174200.00

Skills Desired

Business Continuity Cost Management Operational Excellence Quality Compliance