原液DS生产设备高级经理hz

/ Job Description 负责原液生产工艺设备（上游、下游及配套工艺设备）的整体管理与技术领导，涵盖设备全生命周期管理、设备可靠性提升、项目建设支持、团队管理及持续改进，建立高效、合规、可靠的设备管理体系，保障原液生产稳定运行，支持业务持续增长及全球法规符合性。 Responsible for the overall management and technical leadership of Drug Substance (DS) manufacturing process equipment, including upstream, downstream, and supporting process systems. This role is responsible for equipment lifecycle management, reliability improvement, capital project support, team leadership, and continuous improvement to ensure safe, compliant, and efficient manufacturing operations while supporting business growth and global regulatory compliance. 岗位职责 / Job Responsibilities 1. 设备管理体系建设 Equipment Management System Development 建立并持续优化原液工艺设备管理体系，确保符合GMP、EHS及公司质量管理体系要求。 Establish and continuously improve the DS process equipment management system in compliance with GMP, EHS, and corporate quality

. 制定设备维护策略、技术标准、备件管理标准及设备生命周期管理要求。 Develop maintenance strategies, technical standards, spare parts management programs, and lifecycle management requirements. 推动设备管理数字化、标准化及精益化运营。 Drive digitalization, standardization, and lean operation of equipment management.

2. 02

   设备全生命周期管理 Equipment Lifecycle Management 负责原液生产设备全生命周期管理，包括URS制定、选型、设计评审、采购、FAT/SAT、调试、验证、运行维护及退役管理。 Lead full lifecycle management of DS manufacturing equipment, including URS development, selection, design review, procurement, FAT/SAT, commissioning, qualification, operation, maintenance, and retirement. 确保设备在生命周期内持续满足工艺、法规及业务需求。 Ensure equipment continuously meets process, regulatory, and business requirements throughout its lifecycle. 主导关键设备技术决策和供应商技术管理。 Lead critical equipment technical decisions and vendor management activities.

3. 03

   设备可靠性与维护管理 Equipment Reliability & Maintenance Management 建立设备可靠性管理体系，提高设备可用率和OEE。 Develop and implement equipment reliability programs to improve uptime and OEE. 主导关键设备故障调查、根因分析及CAPA实施。 Lead equipment failure investigations, root cause analysis, and CAPA implementation. 利用数据分析优化维护策略，推动预测性维护及风险导向维护模式。 Utilize data analytics to optimize maintenance strategies and drive predictive and risk-based maintenance programs. 持续降低设备故障率及生产停机风险。 Continuously reduce equipment failures and production downtime.

4. 04

   工艺技术支持 Process Engineering Support 支持细胞培养、收获、层析、超滤/切向流过滤、病毒灭活/过滤、配液等生产工艺运行。 Provide technical support for cell culture, harvest, chromatography, UF/DF, virus inactivation/filtration, and media/buffer preparation operations. 与生产、工艺开发及技术转移团队协作，支持产品引入及工艺优化。 Collaborate with Manufacturing, Process Development, and Technology Transfer teams to support new product introduction and process optimization. 确保设备能力持续满足工艺性能和产能需求。 Ensure equipment capability consistently supports process performance and manufacturing capacity.

5. 05

   项目建设与产能扩展 Capital Projects and Capacity Expansion 参与新建厂房、产线扩建及技术升级项目。 Support new facility construction, capacity expansion projects, and technology upgrades. 作为关键用户参与设计审查、施工调试、CQV及项目交付。 Act as a key stakeholder in design review, commissioning, qualification, CQV activities, and project delivery. 确保项目满足安全、质量、成本和进度要求。 Ensure projects meet safety, quality, budget, and schedule objectives.

6. 06

   GMP合规与审计支持 GMP Compliance and Inspection Readiness 确保设备管理活动符合FDA、EMA、NMPA及其他国际法规要求。 Ensure equipment management practices comply with FDA, EMA, NMPA, and other global regulatory expectations. 支持官方检查及客户审计。 Support regulatory inspections and customer audits. 领导团队处理偏差、变更控制、CAPA及质量事件。 Lead deviation investigations, change controls, CAPAs, and quality-related activities. 持续提升检查应对能力和体系成熟度。 Continuously improve inspection readiness and quality system maturity.

7. 07

   团队建设与人才发展 Team Leadership and Talent Development 负责原液工艺设备团队建设及管理。 Lead and develop the DS process equipment engineering team. 制定人才培养计划，建立技术专家梯队。 Develop talent pipelines and technical expert succession plans. 推动高绩效团队文化建设。 Foster a high-performance and collaborative team culture. 协调跨部门资源，推动业务目标达成。 Coordinate cross-functional resources to achieve business objectives.

8. 08

   持续改进与数字化转型 Continuous Improvement and Digital Transformation 推动设备数字化管理及智能维护平台建设。 Drive equipment digitalization and smart maintenance initiatives. 识别自动化及工业4.0改善机会。 Identify automation and Industry 4.0 improvement opportunities. 持续优化设备成本、能耗及运营效率。 Continuously improve equipment cost efficiency, energy consumption, and operational performance. 任职资格 / Qualifications 教育背景 / Education 本科及以上学历，机械工程、电气工程、自动化、生物工程、化学工程或相关专业。 Bachelor's degree or above in Mechanical Engineering, Electrical Engineering, Automation, Bioengineering, Chemical Engineering, or related disciplines. 工作经验 / Experience 10年以上生物制药或制药行业工艺设备管理经验。 Minimum 10 years of experience in pharmaceutical or biopharmaceutical process equipment management. 至少5年以上团队管理经验。 At least 5 years of people management experience. 具有大型生物制药工厂建设、投产或扩产经验者优先。 Experience in large-scale biologics facility start-up, expansion, or capital projects is preferred. 专业能力 / Technical Competence 熟悉生物制药原液生产工艺及关键设备。 Strong knowledge of biopharmaceutical manufacturing processes and equipment. 熟悉以下设备中的一个或多个领域： Experienced in one or more of the following areas: 生物反应器（Bioreactors） 配液系统（Media & Buffer Systems） 层析系统（Chromatography Systems） 超滤/切向流过滤系统（UF/DF Systems） 病毒灭活及病毒过滤系统（Virus Inactivation & Filtration Systems） CIP/SIP系统（CIP/SIP Systems） 熟悉GMP法规及国际行业最佳实践。 Strong understanding of GMP regulations and industry best practices. 具备设备选型、技术评审及项目管理能力。 Strong capability in equipment selection, technical evaluation, and project management. 具备设备可靠性管理及持续改善能力。 Strong expertise in equipment reliability and continuous improvement. 领导力与综合能力 Leadership & Soft Skills 具备优秀的领导力及团队管理能力。 Strong leadership and people management skills. 具备战略思维及系统化管理能力。 Strategic mindset with strong systems-thinking capability. 具备跨部门协作和影响力管理能力。 Strong stakeholder management and cross-functional collaboration skills. 具备良好的英语书面及口头沟通能力。 Strong written and verbal English communication skills. 优先条件 / Preferred Qualifications 具有FDA、EMA、MHRA、PMDA等国际审计支持经验。 Experience supporting FDA, EMA, MHRA, or PMDA inspections. 具有海外项目或国际化工厂运营经验。 Experience in international manufacturing sites or global projects. 具有设备可靠性工程、TPM、精益生产或运营卓越项目经验。 Experience in Reliability Engineering, TPM, Lean Manufacturing, or Operational Excellence programs.