Support process equipment introduction and process improvements to increase the capability and capacity of WuXi ATU in cell and gene therapies. Apply process engineering principles and GMP knowledge in manufacturing of Advanced Therapy Medicinal Products (ATMPs) to improve and troubleshoot current processes. Directly responsible for meeting user requirements and project schedule for project delivery from feasibility through commissioning/qualification, and hand over to the end users. Coordinate with other functional groups such as EHS, QA, Manufacturing, Testing Operations, Process Development, Facilities, Metrology, Validation, and IT for project delivery.
• Support multiple single-use process equipment projects from conceptual through detailed design, commissioning and qualification for ATMP Manufacturing.
• Applies sound biopharmaceutical process engineering knowledge to optimize current process.
• Perform troubleshooting of process equipment.
• Interface with outside vendors and consultants.
• Support end users to define process equipment User Requirements.
• Interface with client representatives and other functional groups such Manufacturing, Testing Operations, Facilities, Metrology, Validation, and IT, etc. to manage and coordinate the development of design deliverables.
• Review and approve design documentation including engineering calculations, specification and drawings for process equipment/systems.
• Support, review and approve process equipment/system commissioning and qualification protocols.
• Monitor equipment for reliability.
• Review and update process equipment specifications, Process Flow Diagrams and P&IDs.
• 3-5 years of relevant experience
• Working knowledge of current Good Manufacturing Practices (cGMP) in sterile drug manufacturing
• Bachelors’ degree in Chemical Engineering, Mechanical Engineering, or equivalent.
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