DP 8-制剂生产工程师

岗位职责 Responsibilities

无菌生产操作

负责无菌制剂生产相关工作，包括配液、灌装、灯检、贴签等生产操作。

Aseptic Manufacturing Operations

Perform aseptic drug product manufacturing activities, including solution preparation, filling, visual inspection, and labeling operations.

设备操作与维护

负责生产设备的操作、日常维护，并配合设备维修、校验及验证工作，确保设备处于良好运行状态。

Equipment Operation & Maintenance

Operate manufacturing equipment, perform routine maintenance, and support equipment repair, calibration, and qualification activities to ensure reliable equipment performance.

生产文件管理

负责批生产记录、设备使用台账及相关生产文件的填写、审核与管理，确保生产记录真实、完整、可追溯。

Production Documentation Management

Complete, review, and maintain batch production records, equipment logbooks, and related manufacturing documents, ensuring accuracy, completeness, and traceability.

洁净区与物料管理

负责洁净区的清洁、消毒及生产物料管理，确保生产环境和物料状态符合GMP要求。

Cleanroom & Material Management

Perform cleanroom cleaning and disinfection activities and manage production materials to ensure compliance with GMP requirements.

质量与合规管理

参与偏差调查、变更管理及相关文件的起草与执行，协助推动问题整改和持续改进工作。

Quality & Compliance Management

Participate in deviation investigations, change control activities, and related documentation, supporting issue resolution and continuous improvement initiatives.

EHS与合规执行

严格遵守GMP、EHS、数据完整性及公司相关管理要求，确保生产活动符合质量、安全及合规标准。

EHS & Regulatory Compliance

Adhere to GMP, EHS, data integrity, and company compliance requirements to ensure safe, compliant, and high-quality manufacturing operations.

任职要求 Qualifications

教育背景

制药、生物工程、药学等相关专业本科及以上学历；应届硕士毕业生或本科具有3-5年制药生产或工艺相关工作经验。

Education

Bachelor's degree or above in Pharmaceutical Sciences, Biological Engineering, Pharmacy, or other related disciplines. Fresh Master's graduates are welcome to apply; alternatively, candidates holding a Bachelor's degree with 3 to 5 years of experience in pharmaceutical manufacturing, process development, or related functions are encouraged to apply.

专业经验

熟悉无菌制剂生产工艺，有无菌药品生产经验者优先。

Professional Experience

Familiar with aseptic drug product manufacturing processes; experience in sterile pharmaceutical manufacturing is preferred.

设备知识

熟悉无菌制剂生产设备，了解设备运行原理。

Equipment Knowledge

Familiar with aseptic drug product manufacturing equipment and have a good understanding of equipment operating principles.

团队协作能力

具备较强的责任心、执行力和团队协作能力，能够适应生产现场工作节奏。

Teamwork & Execution

Demonstrate a strong sense of responsibility, effective execution capability, and excellent teamwork skills in a manufacturing environment.

办公软件技能

熟练使用Office等常用办公软件，能够完成生产记录、数据整理及相关文件编制工作。

Computer Skills

Proficient in Microsoft Office and other standard business applications, with the ability to complete production documentation, data management, and related record preparation.

综合能力

工作认真细致，具备良好的沟通能力、学习能力和问题解决能力，能够在GMP环境下高效开展工作。

Core Competencies

Detail-oriented with strong communication, learning, and problem-solving skills, and capable of working effectively in a GMP-regulated environment.