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Job Opportunity

Job Opportunity
Manufacturing Technician lll, Downstream
Manufacturing Technician lll, Downstream
United States     Posted 2024-05-01

Position: Manufacturing Tech 3, Downstream

 

Overview:

Responsible for manufacture of biologics products performing activities within production facilities to support the manufacture of downstream operations according to current Good Manufacturing Practices (cGMPs).

 

Responsibilities:

  • Responsible for instrument preparation, downstream purification processing and other clean room operations per cGMP requirement, with some ability to troubleshoot basic on floor operations.
  • Check the relevant manufacturing readiness status including documents, equipment and raw materials for incoming campaigns and report any potential delays and risks identified.
  • Follows, executes, authors, and improves the efficiency and execution of GMP documents, including SOP/MBR/URS/FAT/SAT.
  • Communicate timely with internal team on the process data during a campaign; Identifies, escalates and documents events and variances that deviate from established procedures.
  • Participate in the initiation and investigation of deviations, initiation and execution of change control, implementation of CAPAs.
  • Responsible for cleaning in the clean room per cGMP requirement, such as equipment surface cleaning, periodic cleaning, and changeover cleaning etc.
  • Support the supply chain and Engineering teams on the material ordering, equipment validation, calibration, maintenance and management.
  • Utilizes all support systems (e.g. LIMS) with demonstrated proficiency and is able to act as a subject matter expert (SME) and/or Super user on multiple systems.
  • As team player, may lead shift handover and/or act as shift lead in the absence of supervisor; provide training to less experienced operators.
  • Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi Biologics Policies.
  • Practices and promotes safe work habits and adheres to Wuxi safety procedures and guidelines.

 

Qualifications:

  • Master’s degree in Biology, Chemistry, Chemical/Pharmaceutical Engineering or related Science major. Bachelor’s degree with 2+ years of experience or High School Diploma/GED with 7+ years of work experience in Pharmaceutical industry.
  • Experience in bulk biologics cGMP manufacturing is preferred. Experience in TFF skids, centrifuges, chromatography columns and systems, and/or UF/DF (ultrafiltration/ diafiltration) systems are preferred.
  • Excellent communications skills. Great team player and ability to build positive collaboration with internal stakeholders, vendors and clients to achieve alignment and work effectively.
  • Must work in a self-motivated, highly flexible, well-organized and detailed-oriented style with requirement of some evening conference call time and occasional international travel.