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Manufacturing Engineer


  • Monitor, optimize, and troubleshoot issues related to either 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 process and equipment.

  • Create, review and revise cGMP documents such as batch records, SOPs, etc.

  • Create change records.

  • 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 for the production of recombinant proteins.

  • Serve as subject matter expert for regulatory inspections as well as internal audits and support inspection response.

  • Serve as RSTO representative in global network teams such as UOTs and task forces.

  • Experience in Downstream operations for Drug Substance Manufacturing Operations will be an advantage

  • Collaborate with multidisciplinary teams to achieve project objectives.

  • Assist in experimental design and troubleshooting as needed.

About You:

  • Min. 5 years of experience

  • 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.

Submit your resume to
Only shortlisted candidates will be contacted. 
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