Solution Preparation Engineer

Responsibilities

• Accountable for solution (Buffers and Media) preparation for drug substance manufacturing according to GMP.
  
  
• Accountable for cleaning and component sterilization of production equipment and facilities for drug substance manufacturing according to GMP.
  
  
• Participate in the validation of solution preparation, cleaning and component sterilization of production equipment and facilities.
  
  
• Participate and execute production projects and completing production plans on time.
  
  
• Ensure accurate and timely documentation records in accordance with GMP requirements.
  
  
• Assist in drafting/reviewing/revising SOPs, URS, PQ, MBR and other documents.
  
  
• Participate in continuous improvement program
• Lead deviations and change control management.
  
  
• Participate and support all internal and external audits.
  
  
• Good collaboration across functionally and perform other tasks as assigned by leadership.
  
  

Requirements

• Degree in Biological, Chemical, Pharmaceutical Engineering, or other related specialties; minimum 5 years' experience or candidates with equivalent work experience will also be considered.
  
  
• Ability to adapt to a GMP cleanroom environment, including the requirement to perform gowning and degowning.
  
  
• Possess good communication and comprehension ability.
  
  
• Display good working attitude, strong work ethic, and team collaboration.
  
  
• Able to perform shift work
• Be open to accepting temporary work assignments, including overtime, and other roles as required.