End to end project management for assigned projects: ✓ Work with sponsor to build project business case and support project approval; ✓ Form and lead cross functional project teams to deliver project; ✓ Develop project schedule, monitor status, report to sponsor and stakeholders periodically; ✓ Build Robust Process principles and effective quality control methodology into introduced manufacturing processes during project execution; ✓ Manager project changes, resource and spending; maintain accurate project data in Instants system; ✓ Report project process per plan and escalate risks to sponsor and stakeholders in time; ✓ Work on standard cost calculation and savings estimation; ✓ Work closely with quality to develop validation strategy and validation protocol; ✓ Work closely with planning to coordinate the cut over plan; ✓ Work closely with RA to coordinate product registration; ✓ Work closely with sourcing and supplier quality to build raw material supply base; ✓ Lead project handover and close stability matrix in time for product transfer and NPI projects; ✓ Work closely with local and overseas R&D for project related activities. • Work with manufacturing engineers in process development, machine, tools, jigs, and fixtures selection for projects. • Drive continuous improvement to improve quality/compliance, service and cost. • Understand the Quality philosophy based on FDA QSRs, ISO 9000 and SFDA requirements. • Understand, compile and control non-conformance data and product traceability. • Understand special processes requirements are plus, such as Sterilization, Cleaning, Packaging, FPI etc… • Understand computer software validation requirements. • Perform all job duties in full accordance with: - The J&J policies on Information, Assets protection, Maintain password(s) confidential, protect critical Business Information. - All J&J policies and local regulations. - The policies of the Health Care and Environmental programs. - The code of conduct policies - Propose, develop or participate in actions to improve EH&S • Full responsibility and ownership (like all employees on site) for all audits (internal, Corporate, External, for Quality, H&S, Environment, etc…). • 点到点项目管理 ✓ 与项目发起人合作建立项目业务案例，支持项目审批 ✓ 成立并领导跨部门的项目团队交付项目; ✓ 制定项目进度 ，监控状态，定期进行项目进展报告 ✓ 项目执行期间建立稳定的工艺原理和有效的质量控制方法，再引入到制造工艺 ✓ 管理项目的变化，资源和支出，维护系统中准确的项目数据 ✓ 报告每个计划的项目流程，并及时向项目发起人提出风险 ✓ 标准成本核算和储蓄估算工作 ✓ 与质量部门紧密合作，制定验证策略和验证协议 ✓ 与规划部门密切 合作 ，协调生产计划 ✓ 与RA密切合作 ，以协调产品注册 ✓ 与采购和供应商质量密切合作，打造原料供应基地 ✓ 领导项目切换和及时为产品转移和NPI项目接近稳定矩阵 ✓ 与本地及海外的研发密切协作与项目有关的活动 • 与制造工程师以及工艺工程师协作建议、设计、选择产品需要的机械、工具、夹具和固定装置 • 推动持续改进，提高质量/合规性，服务和成本 • 了解基于FDA QSRs，ISO 9000和SFDA要求质量理念 • 理解，编译和控制非一致性数据和产品的可追溯性 • 了解特殊工艺要求是加成，如灭菌，清洁，包装，FPI等 • 了解计算机软件的验证要求 • 完全按照以下要求履行所有工作职责： - J&J 政策信息，资产保护政策，维护密码保密，关键业务信息. - 所有J&J 政策和当地法规. - 保健和环保计划的政策. - 行为准则政策. • 提出建议，发展或参与改善EH＆S的行动 • 所有审计的全部责任和所有权（如网站上的所有员工）（内部，企业外部，质量，H＆S，环境等）。 **Qualifications** Required Competencies and Skills: ▪ Must have experience of product transfer or new product introduction experience. ▪ Must have cross-functional project management experience in industry. ▪ Must have basic knowledge on machining or related process. ▪ Technical Engineering or Industrial Engineering background. ▪ Strong communication and influencing capability. ▪ Strong project management skills. ▪ Strong understanding for technical drawing. ▪ At least 5 years in manufacturing area, machining area preferred. ▪ Team management experience is preferred. ▪ J&J FPX project leader certification is preferred 所需的能力与技能： ▪ 必须有产品转让或新产品导入的经验 ▪ 必须有在行业的跨职能项目管理的经验 ▪ 必须有机械加工或相关过程的基本知识 ▪ 技术工程或工业工程背景 ▪ 良好的沟通能力和影响力 ▪ 强大的项目管理能力 ▪ 对技术绘图有较强的理解 ▪ 流利的英语 ▪ 制造领域至少5年，加工区优先 ▪ 有团队管理经验者优先 ▪ 获得强生公司FPX项目负责人认证是首选