Reagent Manufacturing Engineer

Danaher CorporationIndianapolis, IN
Onsite

About The Position

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.

Requirements

  • 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.

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.

Benefits

  • Health care program
  • Paid time off
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