Reagent Manufacturing Engineer - NPI & Sustaining

Beckman Coulter Life Sciences; Indianapolis (IN); Sur place; USD 70 000 - 100 000; Plein temps

Avantages offerts par ce poste

Comprehensive benefits

Paid time off

Résumé du poste

Beckman Coulter Life Sciences in Indianapolis seeks a Reagent Manufacturing Engineer to support NPI and sustaining engineering for reagents. You will collaborate with Product Development, Quality, Regulatory, and Supply Chain to transfer products from development to manufacturing.

The role focuses on creating and updating process docs, maintaining equipment, and driving robust, scalable processes for product commercialization within a fast-paced, regulated environment.

Qualifications

• Bachelor's degree in Life Sciences or related technical discipline with at least two years in regulated manufacturing.
• Knowledge of product lifecycle and design control processes.
• Experience writing development and design change documents.
• Proficiency with ERP systems such as Oracle or equivalent manufacturing software.
• Strong analytical, problem-solving, organizational and technical communication skills.

Responsabilités

• 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.

Connaissances

Analytical skills

Problem-solving

Cross-functional collaboration

Technical communication

Project management

Formation

Bachelor's degree in Life Sciences or related field

Outils

Oracle ERP

Description du poste

Beckman Coulter Life Sciences in Indianapolis seeks a Reagent Manufacturing Engineer to support NPI and sustaining engineering for reagents. You will collaborate with Product Development, Quality, Regulatory, and Supply Chain to transfer products from development to manufacturing.

The role focuses on creating and updating process docs, maintaining equipment, and driving robust, scalable processes for product commercialization within a fast-paced, regulated environment.