About Cardinal Health

Cardinal Health is a global, integrated healthcare services and products company connecting people, data, and technology to improve health outcomes. With operations spanning pharmaceuticals, medical products, and supply chain solutions, Cardinal Health serves hospitals, pharmacies, and patients worldwide. In the Theranostics Commercial division in Indianapolis, IN, we specialize in innovative radiopharmaceuticals that advance precision medicine. Our commitment to quality, compliance, and innovation drives us to maintain the highest standards in manufacturing and validation processes.

Role Overview

The Sr. Quality Engineer, Validation position at Cardinal Health's Indianapolis facility is a pivotal role in ensuring manufacturing excellence. Reporting within the Quality Engineering team, you will lead validation and qualification efforts for a state-of-the-art radiopharmaceutical production site. This full-time role demands expertise in FDA-regulated environments, focusing on supplier development, process improvements, and regulatory compliance. With an anticipated salary range of $68,500-$97,800, this position offers autonomy, cross-functional collaboration, and direct impact on cost savings through enhanced raw material quality and reduced waste.

Key Responsibilities

As Sr. Quality Engineer, Validation, your core duties include:

• Conducting and developing validation protocols, projects, and studies to support facility start-up and operations under cGMP and pharmaceutical regulations.
• Maintaining communication with cross-functional teams to address validation challenges and opportunities.
• Providing technical support for equipment qualification, software validation, test method validation, and process validation.
• Developing policies, SOPs, and quality standards aligned with industry, corporate, and FDA requirements (21 CFR 210/211).
• Supporting internal and external regulatory inspections while working with management and contract partners.
• Driving supplier improvements to achieve plant cost reductions via better raw material quality, waste minimization, and inventory optimization.

Daily Impact

You will work autonomously with minimal supervision on projects of moderate complexity, applying judgment to resolve technical issues and ensuring the effectiveness of Cardinal Health's Quality System.

Qualifications & Requirements

To succeed in this role, candidates should possess:

• 2-4 years of experience, with 2+ years as a Validation Engineer, Quality Assurance Engineer, or Quality Validation Consultant in FDA-regulated pharmaceutical or medical device industries.
• Bachelor's degree in a related field or equivalent experience.
• Hands-on experience with validation processes, technology transfer, writing procedures/reports, and laboratory testing execution.
• Proficiency in Microsoft Word and Excel, strong technical writing skills, and the ability to multitask in a detail-oriented environment.
• Preferred: Experience with radiopharmaceuticals.

At this senior level, you will apply working knowledge of quality principles, identify solutions to technical problems, and receive general guidance on new projects.

Benefits & Perks

Cardinal Health provides comprehensive benefits to support your well-being:

• Medical, dental, and vision coverage.
• Paid time off, parental leave, and work-life resources.
• 401k savings plan and health savings account (HSA).
• Flexible spending accounts (FSAs), short- and long-term disability.
• Access to wages before payday via myFlexPay and healthy lifestyle programs.

These perks underscore our investment in employees' health and financial security.

Career Growth

Cardinal Health fosters professional development through hands-on projects, cross-functional exposure, and leadership opportunities. In Quality Engineering, you can advance to roles like Quality Manager or Director of Validation, leveraging our global network. We encourage back-to-work candidates, people with disabilities, non-degree holders, and Veterans to apply, promoting an inclusive culture with tailored growth paths.

Why Join Us

Join Cardinal Health in Indianapolis to contribute to cutting-edge radiopharmaceuticals that transform patient care. Enjoy a collaborative environment, competitive pay, robust benefits, and the chance to lead quality initiatives in a high-growth sector. Our focus on prevention-based methodologies and supplier partnerships positions you for meaningful impact and long-term success.

Role FAQs

What experience is required?

Minimum 2 years in validation within FDA-regulated pharma/medical devices, with expertise in 21 CFR 210/211.

Is radiopharmaceuticals experience necessary?

Preferred but not required; training provided for qualified candidates.

What is the work environment like?

Autonomous role in a manufacturing facility, involving lab work, cross-functional collaboration, and regulatory support.

When does the application window close?

Anticipated 3/21/2026; apply ASAP for consideration.

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