Manufacturing Specialist - Bilingual
WuXi Biologics Germany GmbH
- 经验 不限
作为一名制造专家，你将在车间建立和改进制造流程，作为专家培训和支持操作人员。你将参与生产活动的实施，负责设备/机器的操作，设施和设备的样品清洗，批处理。 你的主要工作职责包括但不限于: 1.建立和改进车间生产工艺 2.作为培训和支持操作人员的专家 3.作为中国中小企业与德国当地运营团队之间的联络人，将中小企业的知识和流程传递给当地运营团队 4.负责调查与运营相关的偏差，变更控制和CAPA 5.负责运营相关文件的编制，包括但不限于sop, mbr，日志，标签等。 6.实施配 方、无菌灌装、VI和包装等功能组的生产活动 7.机器设备在其功能区域内的操作是其主要任务之一。 8.负责MES核心LEV系统和其他电子系统(如PLS)的批处理。 9.负责生产过程中样品、稳定性样品或特殊样品的清洗。 10.负责清洁工作，如有必要，负责清洁工作。灭菌包括设备设施及相关区域的CIP / SIP As a manufacturing Specialist you will build up and improve the manufacturing processes on the shop floor, act as an expert to train and support operational personnel. You will be involved, among others, in the implementation of production activities, responsible for operation of equipment/machine, facilities and equipment sample cleaning, batch processing. Your main job responsibilities will include, but will not be limited to: 1.Build up and improve the manufacturing processes on the shop floor 2.Act as an expert to train and support operational personnel 3.Act as a liaison between China SME and local German operation team, transfer the knowledge and processes from SMEs to local operation team 4.Responsible to investigate the operation related deviations, change control and CAPA 5.Responsible to operation related documentations included but not limited to SOPs, MBRs, logbooks, labels, etc. 6.Implementation of production activities in the functional groups such as formulation, aseptic filling, VI and packaging 7.The operation of machines and equipment in its function area is one of the main tasks. 8.Responsible for batch processing in the MES Core LEV system and other electronic systems such as PLS where applicable. 9.Responsible for cleaning samples, stability samples or special samples during the production process. 10.Responsible for cleaning and, if necessary, for cleaning. Sterilization incl. CIP / SIP of equipment and facilities as well as related areas
所需的资格 1.化学工程或生物科学文凭，有制药或生物技术经验者优先。 2.流利的德语和普通话听说读写能力。 3.工程、生物技术或制药领域的学术背景。 4.有药品生产专业经验者优先。 5.具有GMP和职业安全知识者优先。 行为能力 1.质量意识 2.批判性判断/分析行为 3.良好的组织、合作和沟通能力 4.团队能力 5.可靠性 6.灵活性、弹性 7.高度的自主性，主动性，动态性和目标导向的功能 Required Qualifications 1.Chemical Engineering or Biological Science diploma, pharma or biological technology experience is a plus. 2.Fluent Germany and mandarin in spoken and written. 3.Academic background in engineering, biological technology or pharmaceutical areas. 4.Professional experience in pharmaceutical production is preferred. 5.Knowledge in the areas of GMP and occupational safety is preferred. Behavioral Competencies 1.Quality consciousness 2.Critical judgment / analytical behavior 3.Good organization, cooperation and communication capacity 4.Team ability 5.Reliability 6.Flexibility, resilience 7.High degree of autonomy, initiative, dynamism and goal-oriented functioning
WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. We´re one of the world\'s top three contract development and manufacturing companies for biopharmaceuticals, we provide our clients with a world-leading open access technology platform. We enable our clients to research, develop and manufacture drugs from the concept phase to commercial manufacturing. Our mission is to accelerate and transform discovery, development, and manufacturing in the rapidly growing field of biologics to benefit patients worldwide. We have sites in China, the US, the EU and Asia. We currently employ over 12,000 people and provide services to almost 600 customers worldwide, including the top 20 biopharmaceutical companies. Our vision is \"Any drug can be made, and any disease can be treated.\"