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职位描述

工作地点：天津、上海 具有设计院医药或化工工艺设计者，熟悉生物制药、化学药、中成药、原料药生产工艺、设备选型 职位描述： - 设计及优化生物制药或药厂与其他工艺相关的扩展性/可变性工艺； - 针对生产工艺或扩大生产规模，选择工艺设备，确定关键工艺参数； - 设计、优化和详述新的工艺设备，并编制设备使用说明等文件； - 根据cGMP要求，确保工艺设备具备合格资质； - 对供应商设备的报价分析、比较和选择，供应商跟踪； - 项目前期HSE评估，风险评估； - 工艺流程制定，工艺、仪器装设系统图； - 设计审核，撰写FAT、SAT，对IQ和OQ方案和测试计划给出建议； 其他： - 负责客户、供应商、QA及技术采购之间的协调； - 确保测试项的计划实施； - 财政情况跟踪； - 项目的情况报告。 职位要求： - 至少5年技术背景工作经验； - 具有在以下1个或多个领域经验： n 制药设备； n 布局/ Room Classifications 分级/ 流程； n 清洗和灭菌、灌装技术； n 物料管理和物流； - 熟知GMP和cGMP 者优先； - 良好计算机能力，可以熟练使用P&ID, AutoCAD软件。 Job Descriptions： The employee’s responsibilities are： •Design and optimize scalable processes for biotech or pharmaceutical factory in close cooperation with other disciplines •Select process equipment and determine critical process parameters relevant for design of production process or scale-up •Design, optimize, and specify new process equipment; compile user requirement documents •Qualify process equipment according to cGMP The employee must undertake some of the basic activities in connection with project execution: Basic design: • Establishment of User Requirements Specifications (URS) • Requirements Classifications • Quality Activity Plan (QAP) • Analysis of supplier quotations for machinery & equipment, comparison & selection • Initial HSE evaluation • Risk Assessment • PFD, Process Flow Description • PID, Process & Instrumentation Diagram Detailed Design: • Tender materials and ordering of machinery & equipment • Establishment of project plan • Supplier follow-up • Design Review • Writing FAT, SAT and give input to IQ and OQ protocols and test plans • Execution of FAT, SAT, IQ and OQ Other activities: • Coordination between customers, suppliers, QA, technical purchasing • Secure planning of test items • Financial status & follow-up • Overview of the project Job Requirements： • Minimum 5 years’ technical experience • You have experience in one or more part below: - Pharmaceutical Manufacturing Equipment - Layout/Room Classifications/Flow - Wash & Sterilization, Filing technologies - Warehouse & Logistic • GMP & cGMP knowledge is preferable. • Good computer skill in P&ID, AutoCAD.