工艺设备维护工程师

岗位职责Responsibilities：

1．确保无菌制剂设备在生产中各环节符合国内外GMP要求，支持生产有序进行。

Ensure that sterile preparation equipment meets domestic and foreign GMP requirements in each link of production and support orderly production.

2．为工艺设备调试/确认及验证工作提供支持

Provide support for process equipment commissioning/qualification and validation

3．针对设备存在的问题,提出改进方案.

Provide improvement plan for equipment which have some issues.

4．根据设备情况,提出合理的备件采购建议.

According to the equipment situation, provide suggestions on spare parts procurement

5．组织对已有设备进行工程分析，对设备进行不断的改善，持续改进设备运行状况、运行效率、人机工程，推进成本节约

Organize engineering analysis for current equipment, continuously improve the equipment, continuously improve the operating status, operating efficiency, man-machine engineering, and promote cost saving.

6．负责编写及更新工艺设备维护SOP文件

Responsible for writing and updating SOP documents for process equipment maintenance

7．偏差，变更，CAPA等质量时间的发起，调查，撰写审核等

Initiation, investigation and writing review of deviations, changes, CAPA and other quality time

8．及时真实做好运行记录、维修记录、保养记录等并归档，对设备运行数据进行整理及分析，解决设备出现的各种故障，减少设备的停机时间，降低设备故障率；

Timely filing of operation records, maintenance records, maintenance records, etc., sorting out and analyzing equipment operation data, solving all kinds of equipment failures, reducing equipment downtime and reducing equipment failure rate.

9. 风险评估文件的撰写，能按照FMEA,PHA等主流风险评估工具展开风险评估文件的撰写及法规差距分析

Write risk assessment documents and carry out risk assessment documents and regulatory gap analysis according to mainstream risk assessment tools such as FMEA and PHA

11.审计支持，作为审计联络人，参与审计，提供回复，现场审计陪同讲解，审计问题回复，发现项整改实施协调等

Audit support, act as audit liaison, participate in audit, provide reply, explain accompanying on-site audit, reply to audit questions, coordinate the rectification and implementation of identified items, etc.

12.上级主管交办的其他工作。

Complete other tasks arranged by company supervisor.

任职要求Requirements：

1. 从事过与岗位职责相似的工作，有制药厂相关岗位经历者优先考虑；

Have experience on similar job responsibility, with experience in electronic factory or pharmaceutical factory is preferred.

2. 有电工证、焊工证、压力容器证之一，能够操作氩弧焊的优先考虑；

At least have one of the electrician license, welder's certificate and pressure vessel certificate. The ability of electrical and argon arc welding is preferred.

3. 良好的团队合作和语言表达能力，积极向上的自我进取精神；

Good teamwork and language skills, positive self-enterprising spirit.

4. 具备较好的理解能力、学习能力、沟通能力、发现问题、分析与解决问题的能力;

Good comprehensive ability, learning ability, communication ability, good ability for finding issues, analyzing issues and solving issues.

5. 具备较强的设备故障隐患分析和动手能力，同时也应具备良好的沟通能力;

Good troubleshooting and hand on ability for equipment, good communication ability.

教育背景Education Background：

大专及以上学历，5年以上维修或GMP环境相关工作经验，制药、机械、机电一体化专业的优先考虑；

Diploma or above, more than 5 years working experience in maintenance or GMP environment, pharmaceutical, mechanical and electromechanical integration preferred;

加分项技能Other Skills Preferred:

经历过GMP认证工作，有FDA cGMP或EU GMP认证经历者更佳，熟悉无菌工艺流程，熟悉办公软件，积极良好的沟通能力，注重解决问题，能承受一定的工作压力，良好的中英文听说读写能力。

Having undergone GMP certification, FDAcGMP or EUGMP certification experience is better, familiar with aseptic process flow, familiar with office software, active and good communication ability, pay attention to solving problems, can withstand certain work pressure, good Chinese and English listening, reading and writing ability.

职位亮点：

国际化学习与实践机会：公司提供与国外团队例如新加坡的相关团队交流沟通的机会。员工将有机会深入了解国际行业最佳实践、法规标准，并将其应用于现有工作中，为个人发展和组织提升带来助力。同时，这一机会将帮助员工提升跨文化沟通能力与专业技术水平。

关于药明合联：

药明合联生物技术有限公司（股票代码：2268.HK，以下简称“药明合联”）是全球领先的生物偶联药物合同研究、开发和生产企业(CRDMO)，公司为全球客户提供多样性的创新偶联技术及载荷连接子技术，助力新一代抗体偶联药物（ADC）研发，专注ADC及其他生物偶联药物从早期研发、临床前到商业化生产的一站式服务，涵盖抗体或其他偶联药物中间体、连接子/载荷连接子、偶联原液及偶联制剂等研发和GMP生产。公司在无锡、上海、苏州、合肥、江阴以及新加坡、美国、英国和德国等国家和地区开展运营。

人才是药明合联飞速发展的引擎。公司自2021年成立至2025年底，员工数已从200人迅速突破2600人。我们快速吸纳着全球生物医药行业的优秀人才，并持续打造助力人才成长的平台，以支撑业务的快速稳健发展。我们期待优秀的你加入药明合联，携手共创生物偶联药行业更辉煌的未来！