Waltham, MA

  • Manufacturing Associate II - TFF

    Job Locations US-MA-Marlborough
    ID
    2019-1107
    Category
    Manufacturing & Operations
    Type
    Full-Time
  • Overview

    Inspiring advances in bioprocessing, Repligen is a leader in bioprocess filtration, pre-packed chromatography and Protein A ligands development. Propelled by a culture of innovation and collaboration, and with a focus on cost and process efficiencies, our people and our technologies help meet critical bioproduction demands worldwide.  Named one of the fastest growing biotech companies in the USA, Repligen is headquartered in Waltham, Massachusetts with major manufacturing sites in Massachusetts, California, Sweden, and Germany.  

     

    Our Products

    Repligen offers the broadest range of hollow fiber and flat sheet filtration technologies for cell culture and purification, featuring XCell® ATF Systems, Spectrum® KrosFlo TFF Filters and Systems and TangenX® Flat Sheet TFF Cassettes.  As the expert in pre-packed chromatography technology, Repligen offers OPUS® Pre-packed Columns with unparalleled flexibility and scalability from bench- to production-scale. Since 1985, Protein A affinity ligands manufactured by Repligen have been routinely used to purify most of the world’s monoclonal antibodies. 

     

     

     

    Responsibilities

    • Mechanical assembly and testing of custom TFF systems per assembly drawings, SOP’s, and batch records.
    • Point to point wiring, installation of cables, installation of software, and packaging of final product.
    • 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 and documenting root causes to production issues
    • Able to work independently and be responsible for completion of any manufacturing tasks related to meeting production goals
    • May be asked to participate in other manufacturing operations, as required by management such as inventory control, packaging, and assisting in development activities

    Qualifications

    • Minimum of an A.S. in Technical discipline (e.g.EE Technology, Mechanical Technology, or Engineering, etc.) or 5-7 years of experience
    • Candidates with electro mechanical aptitude preferred
    • Ability to read, understand, and wire per electrical schematics
    • The ideal candidate would be conscientious and self-motivated with a proven track record as a quick learner

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