1 工作职责 / Job Responsibilities

1.1

负责制药生产设备的全生命周期管理，包括选型、安装、调试、维护及退役。

Manage the entire

lifecycle of pharmaceutical production equipment, including selection,

installation, commissioning, maintenance, and decommissioning.

1.2

主导或协助完成设备验证（IQ/OQ/PQ）及再验证工作，确保符合GMP、FDA、EMA等法规要求。

Lead or support

equipment validation (IQ/OQ/PQ) and revalidation activities to ensure

compliance with GMP, FDA, EMA, and other regulatory requirements.

1.3

制定和更新设备管理及验证相关SOP，并监督执行。

Develop and update

SOPs related to equipment management and validation, and ensure implementation.

1.4

协调跨部门（生产、工程、QC、QA）完成设备相关变更、偏差及CAPA处理。

Coordinate

cross-functional teams (Production, Engineering, QC, QA) to address

equipment-related changes, deviations, and CAPAs.

1.5

负责设备档案管理，确保文档完整、可追溯。

Maintain equipment

documentation to ensure traceability and compliance.

1.6

参与内外部审计，提供设备管理及验证领域的支持。

Support internal

and external audits in the areas of equipment management and validation.

2 任职要求 /

Qualifications

2.1

教育背景：本科及以上学历，药学、机械工程、自动化或相关专业。

Education: Bachelor’s degree or above in Pharmacy,

Mechanical Engineering, Automation, or related fields.

2.2

经验要求：3年以上制药行业设备管理或验证工作经验，熟悉GMP法规。

Experience:3+ years in equipment management or

validation within the pharmaceutical industry, with knowledge of GMP

regulations.

2.3

技能要求：

熟悉制药设备（如制剂设备、灭菌柜、 HVAC等）的验证流程。

能独立撰写验证方案、报告及技术文件（中英文）。

熟练使用办公软件及数据分析工具。

Skills:

Hands-on experience

in pharmaceutical equipment validation (e.g., formulation equipment,

autoclaves, HVAC).

Ability to draft

validation protocols, reports, and technical documents in both Chinese and

English.

Proficiency in MS

Office and data analysis tools.

2.4

其他：

良好的沟通能力及团队协作精神。

英语读写流利（需处理英文文档）。

2.5

Others:

Strong

communication and teamwork skills.

Fluent in written

English (for handling regulatory documents).

2.6

优先条件 / Preferred Qualifications

有FDA/EMA认证项目经验者优先。

熟悉计算机化系统验证（CSV）或21 CFR Part 11要求者优先。

Experience in

FDA/EMA-certified projects is a plus.

Knowledge of CSV or

21 CFR Part 11 requirements is preferred.