CSV&DI工程师(J24019)

岗位职责 / Responsibilities

1. 管理无锡合全基地生产设备计算机化系统验证和数据完整性策略，维护并持续优化管理流程。

Manage the computerized system validation and data integrity strategies for the production equipment at the Wuxi STA, and maintain and continuously optimize the management processes.

2. 负责公司GMP相关计算机化系统的验证与日常体系运维，覆盖需求分析（URS）、设计确认（DQ）、安装确认（IQ）、运行确认（OQ）、性能确认（PQ）全流程，起草、审核验证方案、验证报告、需求追踪矩阵、风险评估等相关文件，确保系统验证合规有效

Responsible for the validation of the company's GMP-related computerized systems and the daily operation and maintenance of the systems. This includes the entire process from requirements analysis (URS), design qualification (DQ), installation qualification (IQ), operation qualification (OQ), and performance qualification (PQ). Draft and review validation plans, validation reports, requirement tracking matrices, risk assessments, and other related documents to ensure the compliance and effectiveness of system validation.

3. 建立并持续完善公司数据完整性管理体系，严格遵循ALCOA+原则，覆盖电子数据从创建、采集、处理、存储、备份、恢复、归档到销毁的全生命周期管理，防范数据篡改、丢失等风险，确保数据符合GMP及相关法规要求

Establish and continuously improve the company's data integrity management system, strictly following the ALCOA+ principles, covering the entire lifecycle management of electronic data from creation, collection, processing, storage, backup, recovery, archiving to destruction, to prevent risks such as data tampering and loss, and ensure that the data complies with GMP and relevant regulations.

4. 结合EU GMP附录11计算机化系统，FDA CSA要求，中国GMP计算机化系统，21 CFR Part 11等法规以及行业数据完整性指南，制定差距分析方案和整改计划。

Based on EU GMP Appendix 11 computerized systems, FDA CSA requirements, Chinese GMP computerized systems, 21 CFR Part 11 regulations, and industry data integrity guidelines, develop a gap analysis plan and mitigation plan.

5. 参与公司信息化数字化项目建设，审核项目方案，提供GxP合规需求，确保项目满足GMP及相关法规要求; 协调解决各部门在系统使用、数据管理中的共性问题。

Participate in the implementation of the company's informatization and digitalization projects, review project plans, provide GxP compliance requirements, ensure that the projects meet GMP and relevant regulatory requirements; coordinate and solve common problems in system usage and data management among various departments.

任职要求 / Requirements

1. 本科及以上学历，计算机，自动化，机电一体化相关专业。

Bachelor degree or above. Majors related to computer, automation and mechatronics.

2. 基本英文读写能力。

Basic English reading and writing skills.

3. 5年以上制药企业自动化系统运行、设计经验。

More than 5 years of experience in the operation and design of automation systems in pharmaceutical enterprises.

4. 必须拥有制药行业计算机化系统验证经验。

Must have experience in pharma CSV.

5. 良好的语言表达能力、沟通技巧;

Good language expression ability and communication skills;

6. 一定组织协调能力。

Certain organizational and coordination abilities.