Manufacturing Engineer
7 days ago
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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