Sanofi
Process,PlantandC&QEngineer
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Process, Plant and C&Q Engineer at Sanofi. Skills: Process Engineering, Plant Engineering, Commissioning and Qualification (C&Q), Validation, CAPA, GMP Compliance, Regulatory Audits. Lead the site Process, Plant & CQ team. Ensure sufficient resources for process, plant & CQ activities”
What You'll Achieve.
Ensure sufficient resources available for all process, plant & CQ activities; Ensure CQ standards are in compliance with regulatory requirements; Enhance efficiency, safety, and quality through process improvements
Industry & Context.
Solve the problem occurred during the work independently; Lead investigations & develops CAPAs for unplanned disruptions, breakdowns and deviations
Special training for special operations, Special assignments for special operations
What They're Looking For.
Must Have
Bachelor’s Degree in engineering or equivalent degree, Knowledge of GMP regulatory requirements for CQ activities, Familiar with Assembling & packaging equipment and processes, Good manipulative ability, Sense of responsibility, Good teamwork and communication ability, Can solve the problem occurred during the work independently, Good English writing and communication skills, Technical writing and investigation techniques
Nice to Have
MNC company experience
What You'll Do.
Lead the site Process
Ensure sufficient resources for process
plant & CQ activities
Develop and execute equipment validation protocols (IQ/OQ)
Lead investigations and develop CAPAs for disruptions
breakdowns and deviations
Identify improvement opportunities for critical systems
Act as SME for quality related discussions during audits/inspections
Provide support to Capital Projects
Implement process improvements for efficiency
Participate in commissioning operation procedures
Ensure CQ standards compliance with regulatory requirements
Provide input on resource allocation
and timelines for CQ activities
Manage AL9 group packaging line commissioning and qualification
Advise on system lifecycle changes
Ensure HSE responsibilities are met
Support and implement energy-saving projects
Report product complaints and adverse drug reactions
Participate in and complete training
Operate in accordance with SOP standards
Fill in GMP documents and records
Report abnormal conditions
Perform activities related with Medical Device according to GSP regulations
How You'll Work.
Team & Collaboration
Work with cross-functional teams; Provide support to Capital Projects; Participate in daily + QDCI meetings; Cooperate with accident investigation
Communication Scope
Good English writing and communication skills; Technical writing; Investigation techniques; Cross-functional team communication; Audit defense and justification
Process & Methodology
Resource allocation, Budgeting, Timelines for CQ activities, Support to Capital Projects
Full Job Description
**Job title****职位名称** : Process, Plant and C&Q Engineer 工艺工程师 * Location工作地点： 北京 **About the job工作职责** **Our Team****我们的团队 ：** Manufacturing & Supply consists of 3 manufacturing platforms based on global business units, as well as supporting functions of Quality, Market Supply and Strategy. We are committed to making best class medicines with excellent strategies and tools and delivering them to our patients. _制造与供应事业部包含以_ _3_ _个全球事业部为基础的制造平台 ，以及质量、供应商、精益战略等支持部门。致力于用优异的战略和工具制造优质的药品并传递到患者手中。_ _Take the lead: Aim higher, act for patients, be bold, lead together_ _敢为人先 ：志存高远，心系患者，敢于创新，聚力同行_ **Main responsibilities****职责描述 ：** * _Lead the_ _site_ _Process_ _,__plant & CQ team_ _（_ _internal or external_ _）_ _and ensure sufficient resources available for all process, plant & CQ activities __in accordance with site Q &V procedure._ _主导工厂工艺_ _,__调试与确认团队 （内部或外部），并根据现场需求和战略性人力资源规划，确保所有工艺、装置和调试与确认活动均有充足的资源并且符合工厂_ _Q &V_ _流程要求。_ * _Develop and execute equipment validation protocols (IQ/OQ)__, l_ _eads investigations & develops CAPAs for unplanned disruptions, breakdowns and deviations_ _of Process related_ * _编制并执行设备验证方案_ _(IQ/OQ),__主导调查并制定针对工艺相关意外中断、故障和偏差的纠正和预防措施_ _(CAPA)_ * _Identify improvement opportunities for critical systems in the project phase_ _在项目阶段识别关键系统的改进机会_ * _Act as an SME for a quality related discussions during audits/inspections and provide support to Capital Projects as required_ _在审计_ _/__检查期间 ，作为质量相关讨论的专家，并根据需要为资本项目提供支持。_ * _Implementing process improvements to enhance efficiency, safety, and quality during the project phase and also routine management_ _在项目阶段和日常管理中实施流程改进 ，以提高效率、安全性和质量_ * _Participate in applicable_ _commissioning operation procedures_ _参与与实施调试确认规程的应用_ * _Ensure CQ standards are in compliance with regulatory requirements_ _确保_ _CQ_ _标准符合法规要求_ * _Provide input on resource allocation, budget for process, plant and CQ activities, and timelines for CQ activities_ * _为工艺、工厂和调试与确认活动的资源分配、预算以及试与确认活动的计划提供意见_ * _全流程管理_ _AL9_ _组包装线调试确认工作 ，包括_ _URS,
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