(Sr.)生产设备技术员(原液、制剂)hz

/ Job Description 负责生产工艺设备的运行维护与技术支持，包括原液及制剂生产设备，确保设备稳定运行及符合GMP要求，同时支持设备引入、项目实施及持续优化工作。 Responsible for operation, maintenance, and technical support of process equipment, including drug substance and drug product manufacturing equipment, ensuring stable performance and GMP compliance, while supporting equipment introduction, project execution, and continuous improvement. ________________________________________ 岗位职责 / Job Responsibilities

1. 01

   生产设备运维管理 负责原液及制剂生产设备的日常运行与维护管理。 Responsible for daily operation and maintenance of drug substance and drug product equipment. 制定并执行预防性维护计划，降低设备故障率。 Develop and execute preventive maintenance plans to minimize equipment failures. 保障生产设备稳定运行，支持生产连续性。 Ensure stable equipment operation to support continuous manufacturing. ________________________________________

2. 02

   设备生命周期管理 参与设备全生命周期管理，包括选型、安装、调试、验证及退役。 Participate in full equipment lifecycle management, including selection, installation, commissioning,

, and retirement. 维护设备技术文件及档案，确保可追溯性。 Maintain equipment documentation to ensure traceability. ________________________________________

3. 03

   工艺设备技术支持 为原液及制剂生产提供设备技术支持。 Provide technical support for DS and DP manufacturing operations. 参与工艺优化及设备参数调整，提高生产效率及产品质量。 Support process optimization and parameter tuning to improve efficiency and product quality. ________________________________________

4. 04

   故障分析与可靠性提升 负责设备故障排查、维修及应急响应。 Troubleshoot, repair, and respond to equipment failures. 开展根因分析并推动CAPA实施。 Conduct root cause analysis and implement CAPA. 通过数据分析持续提升设备可靠性及OEE。 Improve equipment reliability and OEE through data-driven analysis. ________________________________________

5. 05

   工程项目及设备改造支持 参与新设备导入及设备改造项目。 Participate in new equipment introduction and retrofit projects. 支持安装、调试及FAT/SAT等工作。 Support installation, commissioning, FAT and SAT activities. 确保设备按计划投产并满足生产需求。 Ensure equipment is delivered on schedule and meets operational requirements. ________________________________________

6. 06

   验证与合规支持 参与设备验证活动，包括IQ/OQ/PQ。 Participate in equipment qualification activities (IQ/OQ/PQ). 支持偏差、变更、风险评估及CAPA工作。 Support deviation handling, change control, risk assessment, and CAPA. 确保所有设备活动符合GMP要求。 Ensure all equipment-related activities comply with GMP. ________________________________________

7. 07

   设备与备件管理 参与设备维护计划及维修策略制定。 Participate in maintenance planning and strategy development. 负责备件需求管理及优化库存。 Manage spare parts requirements and optimize inventory. ________________________________________

8. 08

   数据分析与持续改进 收集设备运行及故障数据并进行分析。 Collect and analyze equipment performance and failure data. 持续改善设备管理水平及运营效率。 Continuously improve equipment management and operational efficiency. ________________________________________ 任职要求 / Job Requirements 教育背景 / Education 本科及以上学历，机械、自动化、电气、生物工程或相关专业。 Bachelor’s degree or above in Mechanical, Automation, Electrical, Bioengineering, or related fields. ________________________________________ 工作经验 / Experience 5年以上制药或相关行业生产设备工程经验。 Minimum 5 years of experience in process equipment engineering in pharmaceutical or related industries. 具备原液或制剂设备经验优先。 Experience in DS or DP equipment is preferred. ________________________________________ 专业能力 / Technical Competence 熟悉生物制药生产设备。 Familiar with biopharmaceutical production equipment. 具备设备运维及故障分析能力。 Strong capability in maintenance and troubleshooting. 熟悉设备验证及GMP要求。 Familiar with equipment qualification and GMP requirements. 具备一定工程项目经验。 Basic experience in engineering projects is preferred. ________________________________________ 综合能力 / Soft Skills 具备良好的沟通能力及团队协作能力。 Strong communication and teamwork skills. 具备较强执行力及问题解决能力。 Strong execution and problem-solving capability. 具备持续改进意识。 Continuous improvement mindset.