Reagent Manufacturing Engineer

Radiometer; Indianapolis (IN); On-site; USD 110,000 - 150,000; Full time

Job summary

Beckman Coulter Life Sciences, a Danaher company, seeks a Reagent Manufacturing Engineer in Indianapolis to drive NPI and sustaining activities for reagent products. You will support transfer from development to manufacturing, ensuring robust, scalable processes for commercial success.

Ideal candidates hold a life sciences degree with 2+ years in regulated manufacturing, strong design control experience, and proficiency with ERP systems.

Qualifications

• Bachelor's degree in Life Sciences, Biomedical, Chemical, Industrial, Manufacturing Engineering, or related discipline with minimum 2 years’ experience in regulated manufacturing environments.
• Knowledge of product lifecycle and design control processes (feasibility, characterization, verification, validation, design transfer).
• Proficiency with writing and developing development & design change documents.
• Strong analytical, problem-solving, organizational, and technical communication skills.

Responsibilities

• Lead reagent Sustaining and NPI projects across cross-functional teams (Product Development, Procurement, Quality, Regulatory, Marketing, Supply Chain).
• Develop and update process documentation for reagent manufacturing cell and equipment (validations, drawings, work instructions, BOMs, routings).
• Ensure timely maintenance and calibration of manufacturing measuring and monitoring equipment.
• Collaborate with operations, suppliers, and customers to troubleshoot and resolve process, product, and component issues.
• Analyze data, prepare reports, and ensure compliance by writing and reviewing study plans, procedures, and documentation within defined timelines.

Skills

Analytical skills

Problem solving

Technical communication

Design control

Education

Bachelor's degree in Life Sciences or related technical discipline

Tools

ERP systems (Oracle)

Job description

About the Role

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Beckman Coulter Life Sciences, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. At Beckman Coulter Life Sciences, we know time is the most critical facet in the laboratory today: time to get life-saving therapies to patients faster; reclaiming time by automating tedious manual workflows; and saving time spent addressing erroneous or complex results. We are partners in time and accelerate answers to critical questions through the power of automation. We develop innovations for scientists by scientists, with many of our 3,300+ global colleagues coming from the laboratory. It’s all part of our time-tested approach to bringing meaningful innovations at the speed of life since 1935. And we’re just beginning. Working together, let’s put our time and talents together to advance human health for tomorrow. Learn about the Danaher Business System which makes everything possible.

The Reagent Manufacturing Engineer serves as the primary engineering interface for new product introductions (NPI) and sustaining engineering for reagents at Beckman Coulter Life Sciences (BEC LS) in Indianapolis. The individual will Support manufacturing operations by providing scientific and engineering expertise to ensure successful transfer of new products from development to manufacturing. Drives sustaining engineering activities to maintain and improve existing processes while ensuring robust, scalable manufacturing processes that support successful product commercialization. This position reports to the Genomics and Reagents Manufacturing Manager and is part of the Manufacturing and Operations Multifunction located in Indianapolis, Indiana and will be an on-site role.

Responsibilities

• Execute reagent Sustaining and NPI projects across cross-functional teams including Product Development, Procurement, Quality, Regulatory, Marketing, and Supply Chain.
• Develop and update process documentation for reagent manufacturing cell and equipment, including validations, assembly drawings, work instructions, BOMs, and routings.
• Ensure timely maintenance and calibration of manufacturing measuring and monitoring equipment.
• Collaborate with operations, suppliers, and customers to troubleshoot and resolve process, product, and component issues.
• Analyze and summarize data, prepare reports, and ensure compliance by writing and reviewing study plans, procedures, and documentation within defined timelines.

Requirements

The essential requirements of the job include Bachelor's degree in Life Sciences, Biomedical, Chemical, Industrial, Manufacturing Engineering, or a related technical discipline with minimum of two years’ experience in life sciences, medical devices, biotechnology, diagnostics, or other regulated manufacturing environments (preferably reagent focused). Knowledge of product lifecycle and design control processes, including feasibility, characterization, verification, validation, design transfer. Technical background in designing and writing essential development & design change documents. Proficiency with ERP systems such as Oracle or equivalent manufacturing software Strong analytical, problem-solving, organizational, and technical communication skills, with the ability to manage multiple priorities in a fast-paced, cross-functional manufacturing environment.

Benefits

Beckman Coulter Life Sciences, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info. Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology.

EEO and Inclusion

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The U.S. EEO posters are available here.

Accommodations

If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or [e-mail].

Additional Information

For more information, visit www.danaher.com.

Danaher is a leading global life sciences, biotechnology, and diagnostics innovator, helping to solve many of the world’s most important health challenges, ultimately improving quality of life for billions of people today, while setting the foundation for a healthier, more sustainable tomorrow.

The Danaher ecosystem is made up of more than 15 businesses united by a shared commitment to innovate for tangible impact.

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