工业化工程师（试剂）

• 岗位设立的目的及目标 / PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB 负责新产品/新工艺的技术转移至生产，为现有产品/工艺提供技术支持和/或改进方案，并参与生产过程的变更控制，质量事件调查等活动。 Responsible as internal point of reference to guaranty the new products/processes transfer to production, to provide technical support and /or improvement to existing products/processes, and to participate in activities including change control process and quality event investigation for manufacturing, etc. 2. 主要职责 / MAIN ACCOUNTABILITIES Safety, Health & Environment /安全，健康和环境  确保符合总部EHS方针、本地法规以及ISO14000的需求。 Ensure compliant to global EHS policy, local regulation and ISO 14000 requirements.  学习、掌握并执行国家、政府职能部门、地方的HSE法律法规要求、标准，履行法规要求的HSE责任和义务。 Learn, master and follow HSE laws, regulations, requirements and standards of the country, government functional departments and local governments, and fulfill the HSE responsibilities and obligations required by regulations.  严格遵守公司HSE规章制度，服从公司的HSE管理，并执行本岗位的HSE管理要求，承诺“不伤害自己、不伤害他人、不被他人伤害，保护他人不受伤害“的四不伤害员工职责。 对被赋予的工作活动做好危害辨识、风险评估、应急预案并确保执行安全操作规范。有责任及时汇报HSE隐患及事故。 Strictly comply with HSE rules and regulations, and implement the HSE management requirements of this position. Promise to follow the requirement ＂do not harm ourselves, do not harm others, do not be harmed by others, and protect others from harm＂. Carry out hazard identification, risk assessment, and emergency plans for assigned work activities and ensure the implementation of safe operating practices. Responsible for reporting HSE hazards and accidents timely. Quality and Regulation/质量和法规  确保遵守国家药品监督管理局相关法规、ISO 13485 标准以及其他适用行业规范，以支持完成公司目标。 Support the company’s goal of ensuring compliance with NMPA regulations, ISO 13485 standard and other industry codes applicable. Project /项目  项目管理：负责诊断试剂从研发向生产转移的工业化的项目工作，制定并跟踪项目转移计划、里程碑、风险控制，推进中试、规模化试生产及量产交接，汇报进展并推动问题闭环。 Project Management: Manage industrialization projects for the transfer of medical diagnostic reagents from R&D to production. Develop and track transfer plans, milestones and risk controls; drive pilot production, scale-up trial production and handover to routine manufacturing; report progress and drive issues to closure.  设计转换和工艺建立：组织或参与研发转移资料的完整性和可制造性评审，将研发输出的的配方、物料清单、原辅料及包材规格、工艺流程和检验要求等转化为受控生产文件，包括工艺规程、标准操作程序、工艺风险分析pFMEA等；与研发、质量共同明确关键质量属性、关键工艺参数和转移验收要求。 Design Transfer and Process Establishment: Organize or participate in reviews of R&D transfer documentation for completeness and manufacturability. Convert R&D outputs, including formulations, bills of materials, raw and auxiliary material and packaging specifications, process flows and inspection requirements, into controlled manufacturing documents, including process instructions, standard operating procedures and process risk analyses (pFMEA). Define critical quality attributes, critical process parameters and transfer acceptance criteria jointly with R&D and Quality.  中试生产和工艺验证：组织中试和规模化试生产,主导工艺研究和工艺验证，方案/报告的的撰写和执行；完成相关培训；联合研发和生产解决中试验证中的工艺技术难点。 Pilot Production and Process Validation: Organize pilot and scale-up trial production. Lead process studies and process validation, including protocol preparation and execution and report preparation; complete related training; and work with R&D and Production to resolve process-related technical challenges during pilot production and validation.  标准样本和配套建立：支持建立生产过程中使用的样本库； 结合研发输入的工作校准品、质控品、质控盘、校准盘及性能样本盘的SOP ， 输出配制、定值和应用文件，并与生产部门协作实施 Standard Samples and Supporting Materials: Support the establishment of a sample bank for use in production. Based on R&D-provided SOPs for working calibrators, quality controls, quality control panels, calibration panels and performance sample panels, prepare documentation for preparation, value assignment and use, and implement it in collaboration with Production.  技术研究： 包含但不限于以下内容：将研发确定的产品参数转化为量产过程中的控制要求；关键原料的生产适用性及批间差异研究和控制方法；校准品、质控品的工艺转换与研发基准的性能可比性； 辅料和包材研究，产品稳定性研究 等等。.

Technical Studies: Activities include, but are not limited to, translating R&D-defined product parameters into controls for routine manufacturing; studying the manufacturing suitability and lot-to-lot variability of critical raw materials and establishing control methods; transferring calibrator and quality control manufacturing processes and assessing performance comparability against R&D benchmarks; and conducting studies on auxiliary materials, packaging materials and product stability.  审计和注册支持：负责与产品转产、工业化研究及工艺转换相关的内审和外审支持；提供注册检验所需的受控样品和工业化研究资料。 Audit and Registration Support: Provide support for internal and external audits related to product transfer to production, industrialization studies and process transfer. Provide controlled samples and industrialization study documentation required for registration testing.

Routine

Operation/日常运营  产品技术相关偏差调查：负责涉及产品技术、产品性能及核心工艺机理的偏差调查。 Product-Related Technical Deviation Investigations: Investigate deviations involving product technology, product performance and underlying mechanisms of core processes.  工艺维护和持续优化：针对量产过程中的工艺波动、性能异常、原料或产品批间差异等问题开展分析，推动关键工序优化及工艺稳定性提升（非日常例行测试或常规生产操作）；已量产产品核心工艺文件的修订和升版；主导工艺风险分析和定期回顾 Process Maintenance and Continuous Improvement: Analyze process variability, abnormal performance and raw material or product lot-to-lot differences in routine manufacturing. Drive optimization of critical process steps and improve process stability, excluding routine testing and standard production operations. Revise and update core process documents for products in routine manufacturing; lead process risk analyses and periodic reviews.  质量事件和变更控制：参与质量事件和变更控制，并作为技术专家给与评估，执行分配的任务 Quality Events and Change Control: Participate in quality event investigations and change control, provide assessments as a technical expert, and execute assigned tasks.  客户端支持：参与告客户书编写，参与客户端技术支持（如必要） Customer Support: Contribute to the preparation of customer notification letters and provide customer-facing technical support when required. 职位要求： 3. 知识、语言和经验要求 / KNOWLEDGE, LANGUAGE AND EXPERIENCE  本科及以上学历，生物、制药、化学等相关专业，需要有至少3-5年以上从事技术转移或工艺开发，或者生产相关的工作经验。 Bachelor degree or above, major in Biology, Pharmacy, Chemistry etc. and necessary to have at least 3-5 years of relevant work experience in technology transfer or process development or production activities  熟悉免疫发光知识背景或IVD 产品研发背景者优先 Knowledge of CLIA technology or rich background on IVD product R&D is preferred  语言技能：必要的英语和中文听、说、读、写能力，有欧美外资企业工作经验者优先。熟练操作Word和Excel等办公软件。 Language skills: Adequate English and Chinese listening, speaking, reading and writing skills.

Experience working for European or American foreign-invested companies is preferred. Proficiency in office software such as Word and Excel.  熟悉ISO 19001, ISO 13485, ISO 14971, GMP等医疗器械及生物安全等相关的法规规范者优先。 Be familiar with relative medical device regulation and bio-security and other codes, such as ISO 19001, ISO 13485, ISO 14971 and GMP ，will be given priority  有良好的团队合作能力。 Good Interpersonal skill and team player.