Associate Manufacturing Engineer

1 week ago

Singapore WuXi XDC Full time

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 higher qualification in Biological, Chemical, Pharmaceutical Engineering, or other related specialties; candidates with equivalent work experience will also be considered.
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.
Career Development
Comprehensive in-house training program (E-learning / OJT / Mentorship)
Dual career development tracks – Professional & Managerial Tracks
Opportunity for internal job rotation / Cross-BU

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