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Job Opportunity

Job Opportunity
Manufacturing Technician l, Downstream
Manufacturing Technician l, Downstream
United States     Posted 2024-03-07

Position: Manufacturing Tech l, Downstream

 

WuXi Biologics is a is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing. WuXi Biologics’ achievements are a direct result of the efforts made by our employees. We have built an extraordinary team motivated by our PROUD culture of Passion, Reward, Opportunity, Unity and Determination. WuXi Biologics offers exciting job opportunities and careers around the globe. We currently employ over 12,000 people and provide services to more than 600 customers worldwide, including all the top 20 biopharmaceutical companies.

 

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 under supervision.
  • Follows and executes per GMP documents, including SOP/MBR.
  • Communicate timely with internal team on floor activities, escalate to supervisor as needed; Document events and variances that deviate from SOP/MBR requirements.
  • Participate in the investigation of deviations and 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 equipment validation, calibration, and maintenance.
  • Utilizes all support systems (e.g. LIMS) as required during GMP production.
  • 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:

  • High School Diploma/GED with 3+ 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.
  • Good 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.

 

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability