公用系统工程师

REQUIREMENTS:

岗位要求：

3年以上公用工程、公用设施或相关设备运行维护经验。

3+ years of experience in utility systems, facility operations, or maintenance-related functions.

5年以上工作经验。

Minimum 5 years of overall working experience.

了解制药行业GMP要求及相关法律法规。

Good understanding of pharmaceutical GMP requirements and applicable laws and regulations.

EDUCATION :

工程类相关专业大专及以上学历。

College diploma or above in an Engineering-related discipline.

岗位职责：

确保所有公用系统按照GMP要求及药明生物内部标准稳定、安全运行。

Ensure all utility systems operate safely and reliably in compliance with GMP requirements and Wuxi Biologics standards.

按照年度预防性维护计划执行公用系统的维护保养工作。

Perform preventive maintenance activities for utility systems according to the approved annual maintenance plan.

配合公用系统工程师确保关键公用系统持续处于验证状态，并参与偏差调查及相关报告的编写。

Support utility engineers in maintaining critical utility systems in a validated state and assist in deviation investigations and report preparation.

能够独立分析公用系统运行状况，识别潜在问题，并提出合理的改进建议。

Analyze utility system performance independently, identify potential issues, and provide effective improvement recommendations.

负责公用系统及关键生产设备的日常运行监控。

Responsible for the routine monitoring of utility systems and critical manufacturing equipment.

确保所有日常工作符合SOP、GMP及其他相关法规要求，并严格遵守公司EHS政策和SOP规定。

Ensure all daily activities comply with SOPs, GMP requirements, and other applicable regulations, while adhering to site EHS policies and procedures.

参与并支持公用系统相关设备和系统的现场验收（SAT）、安装、调试及确认活动。

Participate in and support site acceptance testing (SAT), installation, commissioning, and qualification activities for utility systems and related equipment.

与维修、EHS、质量、生产及实验室等部门保持良好的沟通与协作。

Maintain effective communication and collaboration with Maintenance, EHS, Quality, Production, and Laboratory departments.

完成上级主管安排的其他工作任务。

Perform other duties and assignments as required by the supervisor.

根据业务需要参与倒班工作。

Participate in shift work as required by operational needs.