Responsibilities/工作职责:
• Compliance (EHS/GMP/CUSTOMS)/(EHS/GMP/关务)合规:
Strictly follow regulation\SOP requirements, execute the operations with GMP common sense, fulfil Data Integrity requirements every time, all the time.
严格遵守法规、程序的要求,同时按照GMP常识进行操作,时时刻刻满足数据完整性的要求。
Point out the activities or issues which is not compliance, report to manager in timely manner.
及时指出任何违反合规性的操作和事件,并及时向上级经理汇报。
• Routine Maintenance Work /日常维护工作
Conduct daily inspection, preventive maintenance, and emergency maintenance
执行工艺设备的日常巡检、预防性维护及应急维修
Troubleshoot electromechanical failures, repair transmission systems/electrical controls
诊断处理机电设备故障,完成机械传动系统/电气控制系统的维修
Document maintenance record in time and ensure record complies with GDP requirement
及时完成设备维修记录,确保所有的维修记录符合GDP的要求
• Technical Support and continuous improvement技术支持及持续改进
Continue to reduce process equipment failure by reliability improvement plan
通过可靠性改进计划持续减少工艺设备故障
Optimize the master PM plan and maintenance SOP
持续优化维修主计划和设备维护SOP
Assist maintenance Engineer to control process equipment spare parts inventory
协助工程师控制工艺设备备件库存
Support on technical project and equipment commissioning, qualification and validation
支持技术相关项目以及设备试运行、确认和验证。
Support on CCP, deviation and equipment calibration.
支持设备技术相关的变更偏差及设备的校验。
任职要求
Skills, Performances & Competences required by the position:
岗位所需技能,绩效及能力:
College diploma or above in Electrical Automation or related fields
电气自动化相关专业大专及以上学历
3-5 years in pharmaceutical or electromechanical equipment maintenance
3-5年制药设备或公用系统维修经验
Obtained high and low voltage electrician certificates and experience in high-voltage operation and switching
取得高低压电工证,且具备高压操作和倒闸经验
Proficient in electrical schematics, basic PLC knowledge (Siemens/Mitsubishi preferred)
熟悉电气原理图识读,掌握PLC基础(西门子/三菱优先)
Skilled in maintaining transmission systems, pneumatic components, sensors, etc.
掌握传动系统/气动元件/传感器等典型机电部件的检修技术
Knowledgeable in VFD/servo system commissioning
了解变频器、伺服系统等工业自动化元件调试方法
Fault tree analysis and 5Why problem-solving skills
具备故障树分析思维和5Why分析能力
Adapt to shift work and respond promptly under pressure
适应倒班工作制,能在高压环境下快速响应故障
Strong safety awareness and teamwork
强烈的安全意识和团队协作精神
GMP compliance experience preferred
熟悉GMP法规对制药设备的管理要求者优先