Project Manager/Senior Project Manager (Process)

• Provide technical leadership and direction to ensure design compliance with Global Engineering, SHE, and GMP requirements.
• Oversee design contractors; review OSD, Packaging, and ASRS drawings and specifications to ensure alignment with client standards and local regulations.
• Identify, track, escalate, and resolve critical technical issues and risks during the Basic Design and Detailed Design phases.
• Develop Project Technical Requirement Specifications for OSD, Packaging, and ASRS, defining performance requirements and client standards.
• Participate in SHE risk assessments to integrate risk control measures into designs; optimize for lifecycle cost, reliability, maintainability, and calibration needs.
• Collaborate with cross-functional SMEs to ensure design drawings fully reflect process requirements; provide technical support for supplier alignment and early URS development.
• Conduct design assurance activities and participate in project design meetings as required.

主要职责

• 提供技术指导与方向，确保设计符合全球工程、SHE 及 GMP 要求。
• 管理设计承包商，审核固体制剂、包装及 ASRS 图纸、技术规范，确保满足客户标准与当地法规。
• 在基础设计/详细设计阶段识别、跟进、升级并解决关键技术问题与风险。
• 编制 OSD、包装及 ASRS 项目技术规格书，明确性能要求与客户标准。
• 参与 SHE 风险评估，将风险控制措施融入设计；兼顾全生命周期成本、可靠性、维护与校准需求。
• 与各专业 SME 协同，确保图纸完整体现工艺要求；为供应商及早期 URS 编制提供技术支持。
• 按要求开展设计保证工作，参与项目设计会议。