Manufacturing Engineer

4 weeks ago


Singapur, Singapore Amaris Consulting Full time
Job description About the job
  • Monitor, optimize, and troubleshoot issues related to fermentation/cell culture or protein purification processes and unit operations.
  • Perform product quality impact assessments and support root cause assessments for process discrepancies and Quality investigations.
  • Identify and implement corrective actions, preventative actions, and continuous improvements for processes and equipment.
  • Create, review, and revise cGMP documents such as batch records, SOPs, etc.
  • Perform gap and technical assessments for global standards and procedures (GSPs and SOPs).
  • Serve as risk lead or subject matter expert in support of risk assessments and hazards analysis, e.g., microbial control risk assessments.
  • Develop technical training material and conduct technical training for production staff.
  • Support the technology transfer of new products/processes, e.g., perform field testing.
  • Create, review, revise, and approve technical reports and engineering documents such as URS, FS, SDS, P&IDs, etc.
  • Design, procure, commission, and qualify new equipment.
  • Work effectively as part of a team responsible for ensuring successful and efficient processes to produce recombinant proteins.
  • Serve as subject matter expert for regulatory inspections as well as internal audits and support inspection response.
  • Collaborate with multidisciplinary teams to achieve project objectives.
  • Assist in experimental design and troubleshooting as needed.
About you
  • Bachelor's degree in a relevant life science field (e.g., biology, biotechnology, biochemistry).
  • Previous experience in a GMP environment is preferred.
  • Strong attention to detail, organizational skills, and the ability to work independently or in a team.
  • Excellent communication skills, both written and verbal, in English.
  • Adherence to safety protocols and regulatory compliance.
  • Compliance with cGMP and site safety & security regulations at all times.



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