验证工程师/高级工程师

l 支持公司内各项验证、再验证；审核批准各项验证方案、验证报告及相关文件，如设备/系统确认、工艺验证，清洁验证，无菌工艺模拟、更衣确认，并监督执行，使生产过程在GMP条件下持续稳定进行；支持并审核批准验证偏差调查和处理；

Support the validation and revalidation in the BioInno; review and approve the validation protocols, validation reports and related documentation, such as equipment / system validation, process validation, cleaning validation, aseptic process simulation, gowning qualification, so that the production process can be carried out continuously and stably under GMP conditions; support and approve the investigation and handling of validation deviation.

l 再验证执行，公司内依据法规至少每年要进行的再验证：35套空调系统洁净级别再确认；所有生物安全柜、隔离器、FFU的A级环境或A级送风条件再确认；灭菌柜和在线灭菌系统灭菌功能验证；无菌工艺模拟（半年一次）

Implementation of revalidation: revalidation to be carried out at least annually in the company according to laws and regulations: cleanliness classifications of 35 HVAC systems; class A or class A air supply of all biosafety cabinets, isolators and FFU; Sterilization function validation of autoclave and SIP systems, aseptic process simulation (once every half a year).

l 新项目进入时，审核验证状态与项目匹配性，必要时组织补充验证；

When a new project is introduced, review the matching between the validation status and the project need, and organize supplementary validation if necessary.

l 组织完成公司内计算机化系统清单，组织协调计算机化系统配置、风险评估及验证/再验证以支持公司数据可靠性。

Organize the computerized system inventory preparation in BioInno, organize and coordinate the configuration, risk assessment and validation / revalidation of computerized systems to support data integrity

l 与工程部协调，支持FAT和SAT实施。

Coordinate with engineering department to support FAT and SAT implementation

l 监督验证外包服务。

Be responsible for monitoring outsourcing services of validation.

l 参与公司质量管理体系的运行和维护。

Support operation and maintenance of BioInno‘s quality management system.

l 负责验证仪器管理，包含起草和维护操作SOP、验证仪器台账管理、校准维护。

Be responsible for validation instruments management, including drafting and maintaining operational SOP, establish validation instruments inventory, and calibration maintenance.