Process SME

Process SME – China – Initial 6-Month Contract – Life Sciences 

How would you like the opportunity to support one of the largest biopharmaceutical projects in the country? If yes, then this is the assignment for you!

Our client is currently seeking the skills of a Process SME to support their team. Our client develops and delivers life changing medicines to millions of people globally and as part of their growth. With their Drug Substance (DS) manufacturing network growing rapidly, they are committed to growing their portfolio of commercial biologics products supplied worldwide – and this is your opportunity to be involved!

What you’ll deliver:

• Lead technology selection, process design, capacity modelling, and equipment specification for cell and gene therapy manufacturing.
• Develop and approve URS, risk assessments, and technical documentation to support GMP compliance.
• Support supplier selection, equipment procurement, FAT, commissioning, qualification, and validation activities.
• Collaborate with engineering, construction, and equipment partners to deliver manufacturing facilities and processes.
• Provide technical expertise to manufacturing sites and external partners to improve process performance, quality, and operational reliability.

Experience required:

• Educated to degree standard is desirable (engineering)
• Robust process designs and equipment specifications.
• Approved URS and GMP-compliant technical documentation.
• Successful FAT, commissioning, qualification, and validation execution.
• Delivery of safe, compliant, and scalable manufacturing processes.
• Resolution of technical issues and implementation of process improvements.
  

If this role is of interest to you, please apply now!

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