Production Equipment Sr.Mgr/AD
beigene · 苏州市, 江苏, 中国
About The Role
Position Summary The Production Equipment Senior Manager/Associate Director, will lead the Production Equipment team to ensure equipment compliance, reliability, and efficiency across commercial / clinical manufacturing, new product introduction (NPI), and future business expansion. This role is critical to sustaining GMP/EHS-compliant operations, driving maintenance excellence, and building a strong technical talent pipeline that supports long-term business growth and operational excellence. Key Highlights of the Role • Lead the Production Equipment team to support end-to-end production operations. • Ensure equipment compliance with GMP, EHS, and inspection-readiness requirements. • Drive equipment reliability, maintenance excellence, and efficiency improvement. • Own equipment lifecycle management — from introduction and qualification to upgrade and retirement. • Partner with Production, QA, Validation, Engineering, TS, and EHS to deliver operational and project outcomes. • Build technical capability and a sustainable talent pipeline. Key Responsibilities Equipment Reliability & Maintenance Management • Develop and execute maintenance strategies to ensure equipment reliability and business continuity. • Establish a systematic equipment reliability management framework; track and improve key performance indicators including OEE, MTBF, and MTTR. • Establish and optimize spare parts management strategies. Compliance & Quality Support • Ensure all maintenance and equipment activities comply with GMP, EHS, and company requirements. • Lead or support deviation investigations, CAPA implementation, change controls, and audit readiness based on complexity and business impact. • Maintain equipment documentation in compliance with regulatory expectations. Equipment Lifecycle Management • Lead or support equipment introduction and scale-up for commercial and NPI operations based on complexity and business impact. • Ensure equipment remains in a validated and inspection-ready state. Continuous Improvement & Operational Excellence • Drive process optimization, cost control, and operational efficiency improvements. • Drive systematic root cause analysis (RCA) and failure model assessment to identify, prioritize, and resolve recurring equipment issues. Team Leadership & Talent Development • Lead, coach, and develop production equipment engineers. • Establish clear performance expectations and individual development plans. • Build succession plans and a sustainable technical talent pipeline to strengthen organizational capability. • Drive TPM-aligned operator capability programs, including autonomous maintenance and first-line troubleshooting skills, to reduce engineering dependency and improve equipment availability. Cross-Functional Collaboration • Act as a key technical partner for Production, QA, Validation, Engineering, TS, and EHS. • Collaborate with global and local stakeholders on strategic equipment-related projects. Preferred Profile Education • Bachelor's degree or above in Mechanical, Electrical, Automation, or related engineering disciplines. Experience — Required • Minimum 10 years of experience in pharmaceutical manufacturing equipment management and maintenance. • Minimum 5 years of people leadership experience managing engineering or maintenance teams. • Proven track record in equipment introduction, qualification, and lifecycle management under GMP environment. Experience — Preferred • Experience supporting OSD (Oral Solid Dosage) manufacturing operations. • Experience in facility start-up, expansion projects, or NPI commercialization. • Demonstrated results in continuous improvement, KAIZEN, or Operational Excellence programs. Technical Competencies • Strong understanding of GMP requirements and pharmaceutical manufacturing environments. • Solid knowledge of equipment reliability, preventive maintenance, and root cause analysis. • Familiarity with deviation management, change control, and quality systems. • Knowledge of automation and process equipment systems is preferred. Leadership Competencies • Strategic thinking with a business-oriented mindset. • Strong communication and stakeholder management skills. • Ability to influence across functions and drive sustainable results. • Passion for coaching, team development, and building high-performing teams. 百济神州全球胜任力 当我们通过以下十二项全球胜任力,展现出 "患者为先"、"无界协作"、"锐意创新 "和 "追求卓越 "的价值观时,我们就能帮助全世界更多患者获得更多负担得起的药品。 ●团队协作 ●提供并征求坦诚及可行的反馈 ●自我认知 ●兼容并蓄 ●积极主动 ●开拓精神 ●持续学习 ●拥抱变化 ●结果导向 ●分析性思维/数据分析 ●卓越财务 ●清晰沟通 BeOne Global Competencies When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. ●Fosters Teamwork ●Provides and Solicits Honest and Actionable Feedback ●Self-Awareness ●Acts Inclusively ●Demonstrates Initiative ●Entrepreneurial Mindset ●Continuous Learning ●Embraces Change ●Results-Oriented ●Analytical Thinking/Data Analysis ●Financial Excellence ●Communicates with Clarity 求职者隐私申明: 百济神州致力于尊重和保护您的个人信息权利,并承诺依据合法、正当、必要和诚信的原则处理您的个人信息(包括个人敏感信息 )。 由于百济神州在全球范围内开展业务,我们可能需要基于人力资源管理等合理业务目的而将您的个人信息发送和/或存储在位于您所在国家以外其他国家(例如:美国)的服务器和数据库中,详情参见百济神州《求职者隐私政策》(百济神州官网 - 隐私政策 - 求职者隐私政策)。 如您主动向我们提供您的简历信息或其他个人信息,则视为您已经充分理解并确认接受百济神州《求职者隐私政策》内容。如您对此有任何疑问的,请勿提交简历信息或其他个人信息。 BeOne is committed to respect and protect your personal information rights, and will process your personal information, including your sensitive personal information, based on the principles of legality, legitimacy, necessity, and integrity. 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