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Process Engineer - United States  

Company managed [?] Still accepting applications

Posted on : 22 December 2017

Project Description

We seek a motivated and experienced manufacturing process engineer who will focus on quality and productivity improvements. The position is based in Waltham, MA and will be focused on process support & development for OPUS, ATF XCell and Affinity Ligand product lines. This individual will work closely with Manufacturing and R&D to improve current and new products. The successful candidate will play a key role in ensuring that the department's production and quality goals are met.  The applicant will be the key interface between manufacturing, quality and R&D.  Hands-on mechanical aptitude and an exceptional problem solving ability are important. 

Responsibilities:

  • Serve as a Subject Matter Expert (SME) for multiple bioprocessing manufacturing processes 
  • Implement new product processes in Manufacturing during the transfer from Product Development
  • Research for improvements to support processing of large scale column packing
  • Contribute to the process design for new products during the development phase
  • Develop standardized documentation including  SOP’s, training, validation of equipment, and reports
  • Provide accurate and timely project reporting to internal and external stakeholders
  • Identify and resolve process and quality related problems for assigned manufacturing processes
  • Optimize current processes and identify emerging technologies for future implementation
  • Implementation of corrective actions to solve problems based on root cause analysis
  • Develop and own Process Improvement projects

Qualifications: 

  • Engineering degree or equivalent required
  • 5-10 years of engineering experience in a manufacturing or development environment
  • Demonstrated track record of successful project execution
  • Excellent presentation, verbal, and written communication skills
  • Experience with the operation of laboratory equipment (including pumps, UV detectors, pressure tanks, and various gauges/sensors) and operation of process-scale manufacturing equipment.
  • Experiences with any/all of the following processes are desired: 
    • Chromatography scale up and Packing Chromatography columns
    • Technology transfer between manufacturing sites