NPI & 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

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.