高级技术和工艺开发工程师
纽迪希亚制药(无锡)有限公司
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2017-07-14
- 工作地点:无锡-无锡新区
- 招聘人数:1人
- 工作经验:3-4年经验
- 学历要求:硕士
- 语言要求:英语 熟练
- 职位类别:医药技术研发人员
职位描述
职位描述:
Main responsibilities主要职责:
(1) Propose new & creative process technology ideas for innovation & renovation for NPD or existing
products to meet process expectation, fulfill pilot plant requirements and mass production requirements.
针对新品开发和现有产品提出创新和革新建议,以满足工艺方面的预期、满足研发实验线的需求和商业生产需求。
(2) Further research process and capability of pilot plant, propose process upgrading and modification plan for retort and aseptic technology, Ensure new product development orderly.
深入研究研发实验线的工艺过程和能力,结合业务发展给予最终灭菌技术和无菌工艺技术提供改造升级规划或相关技术支持,确保新品开发有序进行。
(3) Participant new business extension project, take charge or support line manager for new process design, development and validation tasks. Responsible for supporting to issue and to implement an integrity process development procedure, ensure the process meet regulation and products characters, meanwhile fit with the requirement of system.
参与公司新业务发展项目,并负责或协助直线经理完成相关新工艺的设计、开发、验证工作。负责协助实施完整的工艺开发流程,以使设计开发过程符合法规及产品特性,开发的工艺满足法规及客户要求,开发的输出满足体系管理的要求。
(4) Participant and support new process & technology development protocol and draft related technical documents, and support to do test and trial for confirming new technology and process which possible to apply in production line. Give instruction for necessary trial operation.
参与并支持工艺技术开发制定开发方案以及编写一些技术性的文件,并协助进行测试以确定可用于生产的技术与工艺。并给予实验必要的技术指导。
(5) Connect to regional & global process team for new technology development, project sharing and learning.
与区域内兄弟公司或总部工艺团队共同开发新工艺技术、分享项目经验、互相学习。
(6) Support SMART plan for NPD, follow up relevant process research result during processing. maintenance of apparatus or equipment in lab and pilot line.
协助新产品开发方案的制定,执行开发过程中的工艺相关的各项研究考察。
(7) Support to build, maintain and improve the R&D lab management system. Continuously improve the daily
协助研发实验室的体系建立、维护与改进。推动中试研究室的仪器和设备的日常维护和保养体系的改进。
(8) Coordinate new products & new ingredients’ transportation to internal & external manufacturing line. Responsible for project planning & implementation. Lead relevant departments for RA and RFC, finalize PQ implementation.
协调新产品或新原料向内外部生产转移的技术工作,做好方案的策划和实施,带领相关部门做好风险评估和变更管理,并负责验证的实施。
(9) Responsible for sample preparation and management for registration, clinical trial and marketing survey. Initiate and finalize stability test and other technical trial required by registration.
负责制备和管理注册样品、临床试验样品和市场调查样品。并完成注册所需的稳定性试验及其他注册相关的技术试验及报告。
(10) Support to initiate products specification and methodology exploration
协助起草产品质量标准和方法学研究。
(11) Cooperate with line manager to finish the optimization, change or confirmation of recipe and technical formula. Cooperate with supervisor to finish related technical training in company. In order to solve technical problems in commercial production, to collect related data and give technology support. Give instruction to pilot line staffs for daily work.
配合直线经理完成现有工艺的优化、更改和确认,配合完成公司内部的相关技术培训。为解决商业生产中的技术难题,与相关部门有效配合,收集相关数据提供技术支持。对实验室人员进行工作指导。
(12) Initiate & maintain STP to be latest version.
创建并维护现行的工艺技术文件。
Basic job requirement: 基本职位要求:
Education & working experience 学历与工作经验要求:
1. Master degree or above, in Food Science or Food Machinery relevant.
硕士及以上,食品科学技术或食品机械相关专业。
Occupational qualifications职业资格要求:
1. Experience with UHT and DSI research is preferred.
具有UHT和DSI相关技术研究工作经验者优先
2. Independent project management is preferred.
有项目管理经验者优先
3. Excellent MS office skills
能够熟练使用办公软件够熟练使用办公软件
4. Good communication skill
良好的沟通能力
Others其他:
1. Proficient English communication skill (written and verbal)
良好的英语听、说、读、写能力
举报
分享
Main responsibilities主要职责:
(1) Propose new & creative process technology ideas for innovation & renovation for NPD or existing
products to meet process expectation, fulfill pilot plant requirements and mass production requirements.
针对新品开发和现有产品提出创新和革新建议,以满足工艺方面的预期、满足研发实验线的需求和商业生产需求。
(2) Further research process and capability of pilot plant, propose process upgrading and modification plan for retort and aseptic technology, Ensure new product development orderly.
深入研究研发实验线的工艺过程和能力,结合业务发展给予最终灭菌技术和无菌工艺技术提供改造升级规划或相关技术支持,确保新品开发有序进行。
(3) Participant new business extension project, take charge or support line manager for new process design, development and validation tasks. Responsible for supporting to issue and to implement an integrity process development procedure, ensure the process meet regulation and products characters, meanwhile fit with the requirement of system.
参与公司新业务发展项目,并负责或协助直线经理完成相关新工艺的设计、开发、验证工作。负责协助实施完整的工艺开发流程,以使设计开发过程符合法规及产品特性,开发的工艺满足法规及客户要求,开发的输出满足体系管理的要求。
(4) Participant and support new process & technology development protocol and draft related technical documents, and support to do test and trial for confirming new technology and process which possible to apply in production line. Give instruction for necessary trial operation.
参与并支持工艺技术开发制定开发方案以及编写一些技术性的文件,并协助进行测试以确定可用于生产的技术与工艺。并给予实验必要的技术指导。
(5) Connect to regional & global process team for new technology development, project sharing and learning.
与区域内兄弟公司或总部工艺团队共同开发新工艺技术、分享项目经验、互相学习。
(6) Support SMART plan for NPD, follow up relevant process research result during processing. maintenance of apparatus or equipment in lab and pilot line.
协助新产品开发方案的制定,执行开发过程中的工艺相关的各项研究考察。
(7) Support to build, maintain and improve the R&D lab management system. Continuously improve the daily
协助研发实验室的体系建立、维护与改进。推动中试研究室的仪器和设备的日常维护和保养体系的改进。
(8) Coordinate new products & new ingredients’ transportation to internal & external manufacturing line. Responsible for project planning & implementation. Lead relevant departments for RA and RFC, finalize PQ implementation.
协调新产品或新原料向内外部生产转移的技术工作,做好方案的策划和实施,带领相关部门做好风险评估和变更管理,并负责验证的实施。
(9) Responsible for sample preparation and management for registration, clinical trial and marketing survey. Initiate and finalize stability test and other technical trial required by registration.
负责制备和管理注册样品、临床试验样品和市场调查样品。并完成注册所需的稳定性试验及其他注册相关的技术试验及报告。
(10) Support to initiate products specification and methodology exploration
协助起草产品质量标准和方法学研究。
(11) Cooperate with line manager to finish the optimization, change or confirmation of recipe and technical formula. Cooperate with supervisor to finish related technical training in company. In order to solve technical problems in commercial production, to collect related data and give technology support. Give instruction to pilot line staffs for daily work.
配合直线经理完成现有工艺的优化、更改和确认,配合完成公司内部的相关技术培训。为解决商业生产中的技术难题,与相关部门有效配合,收集相关数据提供技术支持。对实验室人员进行工作指导。
(12) Initiate & maintain STP to be latest version.
创建并维护现行的工艺技术文件。
Basic job requirement: 基本职位要求:
Education & working experience 学历与工作经验要求:
1. Master degree or above, in Food Science or Food Machinery relevant.
硕士及以上,食品科学技术或食品机械相关专业。
Occupational qualifications职业资格要求:
1. Experience with UHT and DSI research is preferred.
具有UHT和DSI相关技术研究工作经验者优先
2. Independent project management is preferred.
有项目管理经验者优先
3. Excellent MS office skills
能够熟练使用办公软件够熟练使用办公软件
4. Good communication skill
良好的沟通能力
Others其他:
1. Proficient English communication skill (written and verbal)
良好的英语听、说、读、写能力
职能类别: 医药技术研发人员
公司介绍
纽迪希亚于1995年进入中国市场,并于2000年1月设立工厂并正式投产。这是一家向欧美市场出口肠内营养产品及配套产品的公司,同时也是纽迪希亚全球三大生产基地之一。
纽迪希亚是中国肠内营养理念推广与传播的先行者,目前已经完成了 研发、生产、营销、服务等完整产业生态链的建设。公司主要生产经营肠内临床营养产品(ECN),肠内营养输注产品(Flocare)以及特殊医学用途配方食品(FSMP)。
纽迪希亚坚持以患者为中心,携手政府、医疗机构等社会各方力量,致力于通过创新的产品和业务模式,推动中国医学营养产业的发展,帮助患者延长生命,享受更健康,更有尊严的生活。
纽迪希亚是中国肠内营养理念推广与传播的先行者,目前已经完成了 研发、生产、营销、服务等完整产业生态链的建设。公司主要生产经营肠内临床营养产品(ECN),肠内营养输注产品(Flocare)以及特殊医学用途配方食品(FSMP)。
纽迪希亚坚持以患者为中心,携手政府、医疗机构等社会各方力量,致力于通过创新的产品和业务模式,推动中国医学营养产业的发展,帮助患者延长生命,享受更健康,更有尊严的生活。
联系方式
- Email:HRA@nutricia.com