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Manufacturing Associate II – XCell™ ATF Product Team - United States  

Repligen (company)

Posted on : 22 December 2017

Project Description

This position is for a Manufacturing Associate in the Repligen ATF manufacturing group. The operator will be responsible for all aspects of manufacture, including electronic controller assembly and testing, pneumatic and vacuum solenoid valve assembly and test, system pressure and vacuum testing, system flow calibration, product evaluation, and software testing. This person will also be responsible for documenting all work in production batch records; tracking data in Microsoft Excel and creating SOP’s in Word; operation of laboratory equipment (including pumps, Multi-meters, power tools, hand tools, pressure tanks, and various gauges/sensors) and operation of manufacturing equipment.


  • Operates and maintains production equipment as it relates to manufacturing operations 
  • Maintains records to comply with regulatory requirements. Documents all work on batch records according to Good Manufacturing practices. Performs batch record review as required by Production management
  • Completes ISO9001 QMS documentation, including Batch Records, Forms, Deviation reports, Failure Investigations and Change Controls
  • May be involved in identifying root causes to production issues
  • Responsible for completion of any Repligen Bioprocessing Manufacturing tasks related to meeting production goals
  • Able to work independently, to meet all manufacturing objectives
  • May be asked to participate in other manufacturing operations, as required by management such as inventory control, packaging, and assisting in development activities


  • Minimum of an A.S. in Technical discipline (e.g.EE Technology, Mechanical Technology, or Engineering, etc.) and 3-5 years relevant experience
  • Experience and/or willingness to work in a biopharma manufacturing clean room setting is a must
  • Candidates with electro mechanical aptitude preferred
  • The ideal candidate would be conscientious and self-motivated with a proven track record as a quick learner