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。
- Bachelor's degree or higher in Engineering.
- 10+ years of experience in OSD manufacturing, process design, or equipment installation.
- Deep expertise in OSD equipment, material handling, containment/isolation systems, and GMP regulations.
- Proven experience in equipment selection, procurement, installation, commissioning, and validation in pharmaceutical projects.
- Strong cross-functional collaboration and stakeholder management skills.
- Fluent in written and spoken English; strong problem-solving and execution capabilities.
任职资格
- 工程类本科及以上学历。
- 10 年以上固体制剂生产、工艺设计或设备安装相关经验。
- 精通 OSD 设备、物料输送、密闭/隔离系统，熟悉 GMP 规范。
- 具备制药项目设备选型、采购、安装、调试与验证经验。
- 良好的跨部门沟通与 stakeholder 管理能力。
- 英语读写及口语流利，具备较强问题解决与执行力。
We believe in the power of a diverse and inclusive workforce where the backgrounds, perspectives and life experiences of our people strengthen us. It’s important to us that our recruitment process is easily accessible for you so please click apply for a confidential discussion, as we’re happy to make changes to support the needs of individuals.
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