工程运营高级经理(计量CMMS精益)hz

/ Job Description

负责工程运营团队的日常管理与运营体系建设，涵盖CMMS系统管理、计量与校准管理、设备主数据管理、工程KPIs、精益改善、数字化运营及持续改进等工作，建立高效、规范、数据驱动的工程运营管理体系，持续提升工程组织运营效率、合规水平及资源利用率。

Responsible for the leadership and management of Engineering Operations, including CMMS administration, calibration and metrology management, equipment master data governance, engineering KPI management, operational excellence, digitalization, and continuous improvement initiatives. This role establishes a highly efficient, compliant, and data-driven operational management system to improve organizational performance and engineering effectiveness.

岗位职责 / Job Responsibilities

1. 工程运营体系管理

Engineering Operations Management

负责工程运营团队的日常管理与工作协调。

Lead the Engineering Operations team and manage daily operational activities.

建立并持续完善工程运营管理体系、标准流程及管理机制。

Develop and continuously improve engineering operation systems, procedures, and governance processes.

推动工程资源、流程及管理标准化。

Drive standardization of engineering resources, workflows, and management practices.

支持工程组织战略目标及年度运营计划落地。

Support execution of engineering strategy and annual operational objectives.

2. CMMS系统管理

CMMS Management

负责CMMS系统整体管理与持续优化。

Own and manage the Computerized Maintenance Management System (CMMS).

建立和维护设备主数据、预防性维护计划及备件信息。

Establish and maintain equipment master data, preventive maintenance programs, and spare parts records.

确保维护工单、计划维护、故障维修及设备履历数据完整准确。

Ensure maintenance work orders, preventive maintenance activities, corrective maintenance records, and equipment history are accurately maintained.

推动CMMS数字化应用，提高维护管理效率及数据质量。

Drive digital adoption and continuous improvement of CMMS utilization and data integrity.

3. 计量与校准管理

Calibration & Metrology Management

建立并维护计量管理体系，确保符合GMP及法规要求。

Develop and maintain calibration and metrology programs in compliance with GMP and regulatory

.

负责校准计划制定、执行监督及绩效管理。

Manage calibration planning, execution, and performance monitoring.

确保关键仪表、传感器及检测设备持续处于受控状态。

Ensure critical instruments and measurement devices remain in a qualified and controlled state.

支持偏差调查、审计检查及质量体系活动。

Support deviation investigations, audits, and quality system activities.

4. 工程绩效与数据管理

Engineering Performance & Analytics

建立工程运营关键绩效指标（KPIs）体系。

Develop and manage Engineering KPIs and performance metrics.

定期分析设备可靠性、PM完成率、校准合规率、工单积压率及资源利用率等指标。

Monitor and analyze equipment reliability, PM compliance, calibration compliance, backlog management, and resource utilization.

建立管理驾驶舱及可视化运营报表。

Develop management dashboards and operational performance reports.

利用数据驱动决策与持续改善。

Leverage operational data to drive decision-making and continuous improvement.

5. 精益改善与运营卓越

Operational Excellence & Continuous Improvement

推动精益生产、TPM及运营卓越项目实施。

Lead Lean Manufacturing, TPM, and Operational Excellence initiatives.

识别工程运营中的效率提升机会。

Identify opportunities to improve operational efficiency, productivity, and quality.

推动维护成本优化、资源优化配置及流程改善。

Drive maintenance cost optimization, resource utilization improvement, and process enhancement.

组织工程改善项目并跟踪收益实现。

Lead engineering improvement projects and track business benefits realization.

6. GMP合规与质量体系支持

GMP Compliance & Quality System Support

确保工程运营活动符合GMP、EHS及公司质量体系要求。

Ensure engineering operations comply with GMP, EHS, and corporate quality requirements.

支持审计、检查及客户评估活动。

Support regulatory inspections, customer audits, and assessments.

参与偏差调查、CAPA、变更控制及风险评估工作。

Participate in deviations, CAPAs, change controls, and risk assessments.

持续提升工程组织检查准备度。

Continuously improve engineering inspection readiness.

7. 数字化与智能化建设

Digitalization & Smart Engineering

推动工程数字化转型项目实施。

Drive engineering digital transformation initiatives.

支持CMMS、BMS、EMS、SCADA及数据平台集成与优化。

Support optimization and integration of CMMS, BMS, EMS, SCADA, and engineering data platforms.

探索Predictive Maintenance、AI分析及智能运营应用场景。

Explore predictive maintenance, AI-driven analytics, and smart engineering applications.

提升工程管理自动化及数据价值创造能力。

Improve engineering automation and data-driven operational effectiveness.

8. 团队管理与能力建设

Team Leadership & Capability Development

负责工程运营团队建设及人才培养。

Lead team development and talent growth initiatives.

建立工程运营专业能力体系。

Develop engineering operations competency frameworks.

推动知识管理及最佳实践分享。

Promote knowledge management and best practice sharing.

打造高绩效、专业化工程运营团队。

Build a high-performing and professional engineering operations organization.

任职资格 / Qualifications

教育背景 / Education

本科及以上学历，工程、自动化、机械、电气、工业工程、生物工程或相关专业。

Bachelor's degree or above in Engineering, Automation, Mechanical Engineering, Electrical Engineering, Industrial Engineering, Biotechnology, or related disciplines.

工作经验 / Experience

8年以上制药、生物制药或相关行业工程管理经验。

Minimum 8 years of engineering management experience in pharmaceutical, biopharmaceutical, or related industries.

至少3年以上团队管理经验。

At least 3 years of team leadership experience.

具有CMMS系统实施或管理经验。

Hands-on experience in CMMS implementation or administration.

具有计量校准管理经验。

Experience in calibration and metrology management.

专业能力 / Technical Competence

熟悉工程设施及生产设备管理体系。

Strong knowledge of engineering and manufacturing equipment management systems.

熟悉CMMS、设备资产管理及主数据管理。

Strong understanding of CMMS, asset management, and master data governance.

熟悉GMP法规及设备管理相关要求。

Solid understanding of GMP requirements related to engineering and maintenance.

具备数据分析、KPI管理及运营优化能力。

Strong analytical skills and operational performance management capability.

熟悉精益生产、TPM、六西格玛或运营卓越体系。

Knowledge of Lean Manufacturing, TPM, Six Sigma, or Operational Excellence methodologies.

领导力与综合能力

Leadership & Soft Skills

具备优秀的组织协调及项目管理能力。

Strong organizational and project management skills.

具备跨部门沟通与推动能力。

Strong stakeholder management and cross-functional collaboration skills.

具备良好的问题解决和持续改善能力。

Strong problem-solving and continuous improvement mindset.

具备良好的英语书面及口头沟通能力。

Good written and verbal English communication skills.