Main Job Tasks02主要工作任务 1. Automation tech. work: including design review, FAT, Commissioning, SAT, IOV, PfV, PV and ramp-up, responsible for recover and fix malfunction and keep improvement in whole project progress. Management for technical document and punch-list/open issue list, to ensure project assets completely and technical issue traceability 自动化技术工作:设计审查,FAT,02调试, SAT, IOV, PfV, PV,02达产过程中不断完善系统设计和技术方案,发现解决自动化技术问题.02管理技术文档以及调试遗留问题或待解决问题的列表,保证项目技术资产的完整性以及技术问题的可追溯性。 02 2. Validation work: including document review and approval in different phase of project, take the role as Automation engineer responsibility, handling automation relevant VDV and tests, ensure completely and effective validation to establish and maintain validated state of automation system. 验证工作:包括不同验证阶段中的文档审阅签批,承担验证过程中的自动化负责人的角色并处理自动化相关的验证偏差,审查并签批测试,确保完整有效的验证过程,建立并维护系统的验证状态。 02 3. Communication work, ensure effective communication with all stakeholders. 沟通工作:建立并维持有效的沟通确保所有利益相关方信息一致。 02 4. Continue to share technology and experience and maintain FFEx STJ automation knowledge base 持续技术分享和经验分享,维护FFEx天津厂自动化知识库。 02 02 Skills and Strength:技能和优势 1. Excellent skill in English, both oral and written. 优秀的英语书写和口语沟通能力 02 2. Enjoy collaborating, learning, and sharing information with others, teamwork spirit. Enjoy being close to manufacturing processes and support your stakeholders every day. 良好的沟通和合作能力,善于学习,乐于分享,团队合作精神。乐意服务于生产工艺相关的业务伙伴。 02 Professional Experience专业经验: 1. GMP background: 5+ years manufacturing experience in pharmaceutical automation systems of cGMP/GAMP regulated pharmaceutical industry or in life science industry. Experience with validation/qualification in complex GMP environment. Familiarity with Novo Nordisk validation/qualification methodology, experience with SRV validation approach. GMP02工作背景5年以上年制药行业相关经验并熟悉相关GMP/GAMP5规范。完善的复杂的GMP环境下的验证/确认经验。熟悉诺和诺德验证方法论,02有SRV验证经验。 02 2. Preferable automation experience: 5+ years engineering experience in automation Designing, commissioning, validation, Process Improvement, especially in Wash & Sanitation