锦鲤求职

药明生物

(Sr.)校验工程师

锦鲤会替你打开官网网申、按简历自动填表提交,你只需要在关键步骤确认。

岗位描述

岗位描述 / Job Description

负责厂房内仪表及计量设备的校准及相关技术工作,包括现场校准执行、校准计划落实及数据管理,确保仪器准确可靠并符合GMP及法规要求。

Responsible for calibration and related technical activities of instrumentation and measuring equipment, including on-site calibration execution, implementation of calibration plans, and data management, ensuring accuracy, reliability, and compliance with GMP and regulatory requirements.

岗位职责 / Job Responsibilities

1. 仪表校准执行

负责现场仪表及计量设备的校准工作,包括压力、温度、流量等测量设备。

Perform on-site calibration of instruments and measuring equipment, including pressure, temperature, and flow devices.

按计划执行周期校准,确保设备在有效期内。

Execute periodic calibration tasks according to schedule to ensure validity of instruments.

2. 校准计划与执行管理

根据设备清单制定及执行校准计划。

Develop and execute calibration plans based on equipment inventory.

配合内部及外部校准资源开展校准工作。

Coordinate with internal teams and external vendors for calibration activities.

确保校准按规范完成并符合周期要求。

Ensure calibration activities are completed in compliance with procedures and timelines.

3. GMP 合规与状态管理

确保所有计量设备具备有效校准状态标识。

Ensure all instruments have proper calibration status labels.

避免未校准或超期仪表在生产中使用。

Prevent use of uncalibrated or expired instruments in GMP environments.

支持审计检查并确保记录完整性。

Support audits and maintain complete documentation.

4. 校准数据及报告管理

负责校准数据记录与整理,确保数据完整性及可追溯性。

Record and manage calibration data to ensure integrity and traceability.

审核及归档校准报告。

Review and archive calibration reports.

处理校准超限及异常情况。

Handle out-of-tolerance and abnormal calibration results.

5. 仪表维护与问题处理

协助仪表设备的维护及简单维修。

Support maintenance and minor repair of instrumentation.

参与故障排查并协助解决现场问题。

Assist in troubleshooting instrumentation issues.

提升设备测量稳定性与可靠性。

Improve measurement system reliability.

6. 工程及验证支持

参与新设备校准方案制定及实施。

Support development and implementation of calibration plans for new equipment.

支持FAT、SAT及验证活动。

Support FAT, SAT, and qualification activities.

配合设备安装、调试及投产过程。

Assist in installation, commissioning, and startup.

7. 文件与体系支持

参与校准相关SOP编写及更新。

Participate in writing and updating calibration-related SOPs.

支持偏差、变更及CAPA工作。

Support deviation handling, change control, and CAPA activities.

任职要求 / Job Requirements

教育背景 / Education

本科及以上学历,仪表、自动化、电气或相关专业。

Bachelor’s degree or above in Instrumentation, Automation, Electrical Engineering, or related fields.

工作经验 / Experience

3–5年以上仪表校准或计量相关工作经验。

Minimum 3–5 years of experience in calibration or metrology.

具备制药行业经验者优先。

Experience in pharmaceutical industry is preferred.

专业能力 / Technical Competence

熟悉仪表校准流程及操作规范。

Familiar with calibration procedures and practices.

具备常用仪表校准能力。

Hands-on experience in calibration of common instruments.

了解GMP及计量管理要求。

Basic understanding of GMP and metrology compliance.

具备现场问题处理能力。

Strong troubleshooting capability.

综合能力 / Soft Skills

具备良好的执行力及责任心。

Strong execution and accountability.

具备团队协作能力。

Good teamwork capability.

工作细致严谨。

Detail-oriented and careful.

质量安全方向的申请准备

先核对岗位要求与自己的经历,再准备档案、投递和面试。

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