Product Development Engineer, Reagents

Bruker Corporation•Emeryville, CA

47d•$78,300 - $140,000

About The Position

Bruker is enabling scientists to make breakthrough discoveries and develop new applications that improve the quality of human life. Bruker's high-performance scientific instruments and high-value analytical and diagnostic solutions enable scientists to explore life and materials at molecular, cellular, and microscopic levels. In close cooperation with our customers, Bruker is enabling innovation, improved productivity, and customer success in life science molecular research, in applied and pharma applications, in microscopy and nanoanalysis, and in industrial applications, as well as in cell biology, preclinical imaging, clinical phenomics and proteomics research and clinical microbiology. Today, worldwide more than 8500 employees are working on this permanent challenge at over 90 locations on all continents. Bruker continues to build upon its extensive range of products and solutions, its broad base of installed systems and a strong reputation among its customers. Being one of the world's leading analytical instrumentation companies, Bruker is strongly committed to further fully meet its customers' needs as well as to continue to develop state-of-the-art technologies and innovative solutions for today's analytical questions. The Bruker Cellular Analysis 9BCA) division is looking for a Product Development Engineer for Reagents. As a Product Development Engineer, you will support our company's growing reagent portfolio and manufacturing team. The primary responsibilities of this role will be twofold 1. Qualifying or developing methods for testing new reagent products which can be qualified into production worthy quality control test procedures 2. Performing technical qualification and transfer of products from R&D through process development and to eventual manufacturing team(s) to support scaled production supply.

Requirements

B.S. or M.S. in Chemistry, Chemical Engineering, Materials Science or equivalent with 5-8 years of hands-on experience developing quality test methods in an analytical or manufacturing setting for chemicals/reagents.
Experience performing reagent QC using common analytical techniques: UV-Vis spectroscopy, pH measurements, binding affinity measurements, particle density, etc. This might also include running functional tests on BCA platforms as needed.
Demonstrated problem solving leadership in a manufacturing setting. Ability to drive to the root causes of problems and implement robust solutions.
Experience using and maintaining laboratory equipment (pipettes, biosafety cabinets, centrifuges, vortexers, etc.)
Strong attention to detail with good documentation skills. Demonstrated ability to write comprehensive procedures and reports.
Data-driven, proficient with design of experiments (DOE), statistical analysis, statistical process control (SPC), applies structured problem solving to manufacturing issues, and owns the resolution of manufacturing problems.
Adept troubleshooting skills, including the ability to isolate and resolve component level failures.
High attention to detail.
Well organized, self-motivated, and able to work independently.
Strong interpersonal skills with ability to communicate and interface positively with other team members and departments.
A passion for technology and a willingness to take ownership of results.

Nice To Haves

Relevant experience in the Life Science industry.
Ability to multi-task and prioritize workload to meet deadlines.
Strong aseptic techniques.
Prior experience operating in a clean room environment.
Understanding of Lean Manufacturing Principles and 5S standards.
Experience with manufacturing change control processes.
Preferred experience with GLP/cGMP and ISO quality standards.
Preferred regulatory knowledge.

Responsibilities

Work with technical teams to establish quality control methods and specifications for all raw material components, bulk reagents, and finished good products.
In the spirit of continuous improvement, evaluate QC methods, quality controls, and production processes to ensure delivered products meets expected quality and performance standards
Creates and executes test and validation plans based on production specifications and requirements.
Works cross functionally and partners closely with R&D in the product design process in addition to manufacturing to span technology transfer seamlessly between the functions.
Define and iterate on business processes to stream
Stability test method development and characterization for existing and new products and their raw material components
Serve as technical liason for all reagent product quality excursion events, identify and clearly communicate causes and corrective action plans within the organization, and implement changes to prevent recurrence.
Manage supplier material quality and drive resolution of quality issues with supplier through corrective and preventative actions.
Review and revise manufacturing work instructions and procedures as needed to ensure product fitness for use
Provide support for synthesis and analysis of quality data
As needed for supporting surge demand or higher complexity products, support production execution of reagents
Support record keeping in the manufacturing execution system (MES), enterprise resource planning (ERP), and product lifecycle management (PLM) softwares.

Benefits

Full-time employees may also be eligible for a performance-related incentive in addition to a full range of benefits including 401(k) with company match, an employee stock purchase plan, medical and dental plans, life insurance, short-term and long-term disability insurance, employee assistance program and paid time off including vacation, sick time and holidays, and more.

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