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**Job Function: **
Supply Chain Engineering
**Job Sub Function: **
Process Engineering
Job Category:
Scientific/Technology
All Job Posting Locations:
Xian, Shaanxi, China
Job Description:
*主要职责***PRINCIPAL RESPONSIBILITIES: **
- 在有限的指导下负责和协调APIs/辅料包材物料供应商切换项目、工艺改进项目、技术转移以及新技术引入项目等，包含以下主要活动：Leads and coordinates projects for Source change of APIs/Excipients/Packaging materials, Process improvements, Technical transfer and introduction of new technology under supervision including as needed:
- 组建核心团队，根据FPX启动并管理项目时间表；Setting up the core team, kicking off the project along the FPX procedures and managing project timeline;
- 追踪核心团队成员完成可交付的成果；Follow up core team members to achieve deliverables.
- 通过完成项目的里程碑以及重要事项，实现项目的目标；Realize the project outcomes through the project milestones and deliverables.
- 完成技术转移，包括试验批、验证批和报告；Completes the technical transfer, including development batches, validation batches and reports.
独立有效地推进相关的验证工作，包括工艺验证、包装验证和清洁验证。能够草拟验证草案和报告；Drives related validations independently and efficiently that include process validation, packaging validation and cleaning validation. Be capable of designing validation protocol and report.
完成工厂不符合事件的调查，通过使用科学的解决方案和六西格玛方法来确定并证实问题的根本原因；Completes investigations for site process non-conformances by using scientific problem solving and six sigma techniques to determine and then prove the root cause.
根据各个具体项目，能够使用统计学方法分析技术数据；Be capable of analyzing technical data using statistical analysis according to each specific project.
能与重要的利益相关方进行有效沟通，并加快解决业务合作伙伴复杂的问题。Efficiently communicates within stakeholders and facilitates resolution of less complex business partner issues.
确保cGMP，财务以及其他法规的完全合规。Ensures full compliance with cGMP, Finance and other regulations.
*知识技能要求***KNOWLEDGE SKILL AND ABILITY REQUIREMENTS: **
*1. 专业知识Specific knowledge*
- 具备深厚的制药工艺和产品、清洁、设备方面的技术知识，包括固体和非固体剂型，特别是片剂/胶囊剂乳膏剂/栓剂。Strong expertise on pharmaceutical manufacturing processes and products, cleaning, equipment with focus on solid and non-solid products, especially Tablets/Capsules/Creams/Suppository.
- 具有在多文化背景下的工作经验, 具备良好的英语沟通能力（口语和书面），能胜任一定的跨国团队技术沟通、技术文档撰写及国际审计交流。Good in English for cross-cultural technical communication, technical documentation, and international audits.
- 具备一定的制药法规经验，了解中国NMPA药品注册法规、GMP要求。Have experience and knowledge of pharmaceutical regulations and GMP requirements.
- 项目管理，组织、计划和协调能力。Project management, organizing, planning and coordination skills
- 熟知流程优化（六西格玛），精益思想和工具。Process excellence (6sigma), lean concepts and tools
- 具备深厚的质量、合规、法规要求（GMP/EH&S）等知识，尤其是技术平台概念。Strong knowledge of Quality & Compliance / regulatory requirements (GMP/EH&S) especially for Technology Platform
*2. 个人（领导力）技能Personal and interpersonal skills / Leadership skills*
- 能承受工作压力，处理各种利益冲突，并作出决定Ability to work under pressure, handle conflicting interests, and take decisions.
- 能够在遵循大方向的前提下独当一面，对指派的任务目标优先级具有良好的判断能力，并管理好相应的时间Ability to work independently under general direction, having a good sense of prioritization of assigned tasks goals and manage time accordingly.
- 以客户和业务为重Costumer and business focus.
- 有良好的团队合作精神Team player.
*3. 个人态度和心态Personal attitude and mindset*
- 具有创新精神，勇于改变来确保竞争力Drives for innovation and change to ensure competitiveness.
- 具有乐观进取的心态，能够灵活处理工作中的延展性目标，并达成该目标Can-do mentality, agility & flexibility able to work with stretched goals and deadlines.
- 在专业活动中具有很高的责任心Showing a high sense of responsibility regarding professional activities.
*4. 良好的生产规范Good Manufacturing Practices (GMP)*
- 坚持遵守cGxP的程序Adhere to applicable cGxP’s and procedures (role model)
- 报告事故和偏差Report incidents and deviations.
- 提出改善符合GMP的解决方案Propose solution to improve compliance with cGMP’s.
*5. 安全，健康和环境绩效Safety, Health and Environment Performance*
- 坚持遵守EHS&S的程序Adhere to applicable EHS&S and procedures.
- 正确使用可利用的个人及集体保护设施Correct use of the available personal and collective protection materials.
- 报告事故，偏差Reporting of (near) accidents, incidents, deviations
- 配合和建议方案提高EHS程序Cooperate on and suggest solutions to improve EH&S
- 当看到违反EHS规则的行为要及时制止，做出适当的行动
- Act when violation of EH&S rules is observed and stimulate appropriate behavior
相关要求****Related Requirements:
- 制药领域至少5年以上工作经验，和/或同等学历和经验。A minimum of 5 years of experience in a pharmaceutical environment. And/Or an equivalent combination of education and experience:
- 学位DEGREE：药学、工程学或理科本科学历、硕士学历或同等学历。University degree in Pharmaceutical science, Engineering or Science Bachelor’s Degree or Master’s Degree in Equivalent.
**Required Skills: **
Preferred Skills:
Analytical Reasoning, Computerized Equipment Skills, Emerging Technologies, Gemba Kaizen, Issue Escalation, Lean Supply Chain Management, Problem Solving, Process Control, Process Engineering, Process Oriented, Product Improvements, Science, Technology, Engineering, and Math (STEM) Application, Situational Awareness, Supply Planning, Technical Research, Technologically Savvy, Validation Testing