Manufacturing Engineer

2 days ago


Singapore WuXi XDC Full time

Responsibilities Culture antibody intermediates in 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. Adapt to a GMP cleanroom environment, including requirement to wear dust-free clothing, masks, and goggles. Good communication ability and comprehension ability. 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. #J-18808-Ljbffr



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