厂务主管(医疗)
On-siteShenzhen Shenzhen, Guangdong, China
Job Summary
Lead a team of facilities technicians to maintain the medical workshop and ensure production environments meet medical-grade cleanliness standards. Oversee daily operations of water, electricity, gas, and HVAC systems while managing preventive maintenance, upgrades, and emergency repairs for building and utility infrastructure. Establish and enforce comprehensive environmental health and safety (EHS) programs, including regular disinfection schedules and pest control management to prevent microbial and contamination risks. Ensure full compliance with FDA, GMP, and ISO 13485 regulations by managing facility audits, annual inspections, and obtaining necessary permits. Develop and update standard operating procedures (SOPs) and lead training initiatives for all staff to guarantee operational proficiency. Coordinate cross-departmental efforts for new workshop construction, equipment validation (IQ/OQ/PQ), and continuous efficiency improvements.
Required Qualifications
- Bachelor's degree in Industrial Engineering
- 4 - 7 years related experience
- Strong knowledge of global and regional logistics operations and industry
- Strong proficiency in determining logistics requirements to enable company's business goals and objectives with ability to devise and implement strategy to achieve targets
- Strong financial and analytical ability
- Proficiency in managing business analytics to determine optimum company footprint
- Strong knowledge of international direct and indirect taxes as well as global customs regimes
- Proven track record of successful change management accomplishments, implementing and management continuous productivity and cost reduction programs
- Strong and convincing communication skills
- Proficiency in use of personal computers, Microsoft Office products (Excel, Word and PowerPoint) and e-mail skills
- 3 年以上医疗器械、制药或食品行业厂务管理经验
- 具有同等岗位管理经验者优先
- 必须熟悉 GMP 规范、FDA 相关法规及 ISO 13485 医疗器械质量管理体系
- 能够独立应对相关法规的审计与检查
- 熟悉洁净室 (Cleanroom) 管理标准及环境监测要求
- 熟悉 HVAC 系统、纯化水/注射用水系统、压缩空气系统等公用工程的运行原理及维护要点
- 具备丰富的消杀及虫害防治实操经验
- 了解相关药剂特性及消杀流程
- 具备优秀的文档编写能力
- 能独立起草、修订及审核各类厂务管理文件
- 具备较强的组织协调能力
- 具备突发事件应急处理能力
- 工作严谨细致
- 责任心强
- 具有良好的跨部门沟通与培训指导能力
Desired Qualifications
- 暖通、机电、制药工程、生物工程或相关专业优先
- 持有特种设备安全管理、电工证、制冷证等相关职业资格证书
- 有主导或参与过药监局 (NMPA) 或 FDA 现场认证检查经验者优先
- 具备良好的英语读写能力
- 能阅读英文设备说明书或法规文件
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