Manufacturing Support Biotechnologist

2 days ago

West Region, Singapore WUXI XDC SINGAPORE PRIVATE LIMITED Full time $40,000 - $80,000 per year

Component Support Operator / Biotechnologist

Department: Manufacturing Support

Work Location: Tuas Biomedical Park

Responsibilities:

  • Attend daily shift handover and staff meetings and work closely with teammates, various stakeholders and external vendors.
  • Perform components cleaning using parts washer and manual components cleaning by following standard operating procedures for drug substance manufacturing in GMP cleanroom environment.
  • Perform preparation of assemblies and autoclave activities by following standard operating procedures for drug substance manufacturing in GMP cleanroom environment.
  • Draft/Author and provide inputs in documentations such as user requirement specifications, standard operating procedures and batch records etc.
  • Support commissioning and validation activities, coordinate with various departments to keep track on the commissioning and operational progression to ensure project milestones are met.
  • Perform and lead root-cause analysis for deviations and investigations using problem solving tools such as fish-bone diagram etc.
  • Complete production batch records timely and accurately according to Wuxi XDC good documentation practice.
  • Complete all relevant GMP trainings before start of GMP operations.
  • Follow company EHS policy and maintain a safe work environment for everyone.
  • Complete daily assigned tasks on time with minimum supervision and inform any production issues to supervisor.
  • Perform routine 5S housekeeping and ensure the shopfloor is clean and tidy.
  • Suggest continuous improvement initiatives to increase production efficiency and quality.

Qualifications:

  • Diploma or Bachelor's degree in life sciences and engineering discipline. (Biological/Pharmaceutical Science/Chemical Engineering/Life Science/Chemistry) with 2 to 5 years relevant experience
  • Plant Start-Up or commissioning, and operational experience in biologics/vaccines will be an advantage
  • Knowledge/Experience of current Good Manufacturing Practices and Good Documentation Practices applicable to Material Preparation Processes such as Parts Washer Cleaning and Autoclave Operations is desirable
  • Well organised and detail-oriented, eager to learn and able to work effectively with various stakeholders in a team environment.
  • Good Team player with good working ethics, takes initiative, integrity and have the positive drive.
  • Good communication skills and writing skills
  • Experience with Problem Solving Skills
  • Able to work in the cleanroom environment

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