MSAT Engineer, DP

Reponsibilities:

• Understand and comply with company's policies, particularly in IP (Intellectual Protection)
• Ensure the compliance with EHS requirements in daily work
• Draft gap analysis, risk assessment, technology transfer protocol and process flow diagram for new transfer project
• Lead gap analysis, risk assessment, change control and technology transfer protocol for cross-site late stage project
• Lead the process validation activities, including change controls, process control strategy, PPQ/supportive study protocols, define and identify CQA/CPPs, be trainers, CPV compaign, comparability study etc
• Working with cross function teams and determine the details of technology transfer and solve related problems
• Responsible for establishing and maintaining the knowledge platform for technology transfer
• Support the optimization of DP manufacturing process
• Support technology transfer related documentation management
• Support the investigation of deviations during technology transfer

Requirements:

• Bachelor degree or above, major in Microbiology, Chemistry, Biotechnology, Biochemistry or any other relevant education.
• 5 years+ work experience within biopharmaceutical industry
• Familiar with aseptic assurance and GMP regulation, understanding Drug Product process development