Manufacturing Engineer (Pharma/Biotech)

Responsibilities:

• 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.
  

Duration:
12 months. Option to extend depending on business needs.