设备/仪器管理SME(研2-副高，活性/生化/药典仪器方向)

1. 01

   负责GMP活性/生化/药典实验室仪器的日常管理工作，确保仪器正常运作，符合GMP和公司质量体系的要求。 Responsible for the daily management of GMP bioassay/biochemistry/ compendial laboratory instruments to ensure proper operation and compliance with GMP and company quality system

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2. 02

   执行实验室设备PM、校准和验证计划，并负责与供应商联系沟通，确保仪器按时完成相关工作。 Execute preventive maintenance (PM), calibration, and validation plans for laboratory equipment, and coordinate with vendors to ensure timely completion of related tasks

3. 03

   确保在分析仪器生命周期内活动遵守系统管理/维护规程的要求进行，包括但不限于账户管理，系统配置，备份管理和审计追踪管理。 Ensure compliance with system management/maintenance protocols throughout the lifecycle of analytical instruments, including but not limited to account management, system configuration, backup management, and audit trail management.

4. 04

   及时响应实验人员的仪器报修，并及时解决相关维修。涉及仪器包括但不限于酶标仪、细胞计数仪、PCR、药典类仪器等，并及时汇总维修数据，以指导用户减少维修，提高维修恢复速度。 Promptly address instrument repair requests from laboratory personnel, covering equipment such as plate reader, vicell, PCR, compendial instruments etc., and compile maintenance data to guide users in reducing downtime and improving repair efficiency.

5. 05

   负责处理分析仪器/设备的质量事件，包括但不限于法规差异分析、偏差、变更、纠正和预防措施等。 Handle quality events related to analytical instruments/equipment, including regulatory discrepancy analysis, deviations, changes, corrective and preventive actions (CAPA), etc.

6. 06

   应用WBS(WuXi Business System) 工具优化工作流程，提高生产力，解决问题。 Utilize WBS (WuXi Business System) tools to optimize workflows, enhance productivity, and resolve issues.

7. 07

   支持和参与公司内外部审计及法规审计。 Support and participate in internal/external audits and regulatory inspections.

8. 08

   主管其他指派的工作（如有）。 Perform other duties assigned by supervisors (if applicable). 任职要求 教育背景： 本科及以上学历，生化、化学或相关专业背景 BS degree or above in biochemical, chemistry or related scientific field 工作经历 ：三年以上工作经验，具有GMP体系经验、仪器管理经验或其他同等工作经验。有自动化工作站的验证和管理经验者优先 At least 3 years of working experience, with hands-on experience in GMP systems, instrument management or equivalent fields. Experience in validation and management of automated workstations is preferred. 专业知识及技能要求:

9. 01

   了解制药行业QC/分析实验室仪器管理流程。 Familiar with QC/analytical laboratory instrument management processes in the pharmaceutical industry

10. 02

    了解仪器管理的相应法规，如USP1058等 Knowledge of relevant regulatory requirements for instrument management (e.g., USP 1058)

11. 03

    有编程、小程序开发或PBI看板编辑经验者优先 Candidates with experience in programming, mini-program development, or Power BI dashboard creation/editing will be preferred. 其他技能或经验要求：

12. 01

    沟通能力：与业务团队和供应商协作，明确需求并制定解决方案，推进业务。 Communication Skills: Collaborate with business teams and suppliers to clarify requirements, develop solutions, and drive business initiatives

13. 02

    问题解决：快速定位问题（如资源不足、规则矛盾）并提出妥善的方案。 Problem Solving: Quickly identify issues (e.g., resource constraints, conflicting rules) and propose effective resolutions.