Manufacturing Engineer

2 weeks ago

Tuas West Region, Singapore WuXi XDC Full time $90,000 - $120,000 per year

Manufacturing Engineer – Cell Culture

Responsibilities

  • Cultivate and express antibody intermediates in an industrial-scale cell culture platform using single-use technologies.
  • Perform vial thawing, cell expansion and passage, cell culture, and harvest manufacturing in drug substance facilities in accordance with GMP requirements.
  • Operate equipment and appliances following the guidance of SOPs and relevant documents.
  • Prepare relevant documents, such as production batch records, SOPs, and validation reports.
  • Communicate and resolve any inconsistencies and/or anomalies in production operations.
  • Monitor processes, including real-time review of process parameters and process data/trends.
  • Ensure that the manufacturing operations for drug substances comply with quality and safety regulations.
  • Perform other tasks assigned by leadership.
  • Participate in shift production as required and ensure that shift production meets SOP requirements.

Requirements

  • Diploma or Degree in Biological, Chemical, Pharmaceutical Engineering, or other related specialties with min 3-5 years of relevant working experience
  • Possess thorough scientific reasoning and methodical work habits, with strong execution and planning abilities.
  • Ability to adapt to a GMP cleanroom environment, including the requirement to wear dust-free clothing, masks, and goggles.
  • Possess good communication ability and comprehension ability.
  • Display a good working attitude, strong work ethic, and willingness to follow leadership directives.
  • Be open to accepting temporary work assignments, including overtime on weekends or weekdays, and other roles as required.

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