Manufacturing Engineer

2 weeks ago

Singapore Wuxixdc Full time

Direct message the job poster from WuXi XDC Senior TA Specialist of the Bioconjugate Leader 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. Seniority level Mid-Senior level Employment type Full-time Job function Quality Assurance Industries Pharmaceutical Manufacturing We are an equal opportunities employer and welcome applications from all qualified candidates. #J-18808-Ljbffr

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