- Location
- CHN - Shenzhen - Plastics, China
- Type
- Full-time
- Education
- Bachelor
- Source
- Workday
Description
JOB SUMMARY
To lead a team of facilities technicians to maintain the factory building, its surrounding premises, production plant service including preventive maintenance and upgrading of facility equipment and electrical services.
ESSENTIAL DUTIES AND RESPONSIBILITIES
· Responsible for preventive and routine maintenance; overhaul and modification of building and production equipment; emergency repair of buildings, equipment and utility systems
· Assumes responsibility for complete in-house janitorial service and ground maintenance.
· Assumes responsibility for site environmental compliance programs.
· Assures all Federal, State and Local permits are obtained and continue current.
· Acts as liaison to public utility, environmental and energy agencies.
· Assures that all electrical, mechanical and construction work is performed in conformance with applicable codes and regulations.
· Assumes responsibility of Safety Officer. Assures that each employee is formally trained in safety, which includes knowledge of hazards and protective measures required to prevent injury or illness.
· Establish and maintain the building's operational flexibility. Evaluate and carry out improvements for higher operational efficiency in plant utilities.
· Responsible for all electrical safety.
· Plan and ensure monthly budget accuracy.
· Plan, coordinate and ensure all facilities works compliance with required specifications, regulatory requirement, quality of work and safety standards.
· Support and assist the Functional Manager with day to day activities.
· Drive continuous improvement in all aspects of facilities operations in terms of cost, performance and efficiency.
· May perform other duties and responsibilities as assigned.
JOB QUALIFICATIONS
KNOWLEDGE REQUIREMENTS
· 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 required.
EDUCATION & EXPERIENCE REQUIREMENTS
· Bachelor's degree in Industrial Engineering.
· Plus 4 - 7 years related experience.
· Or a combination of education, experience and/or training.
职位名称：医疗车间厂务主管
一、岗位职责
1. 车间与设施管理：全面负责医疗车间的日常运营管理，确保生产环境符合医疗级洁净度要求；统筹管理水、电、气、暖通空调（HVAC）等公用设施设备的运行、维护与保养，保障生产的连续性与安全性。
2. 环境健康与安全（EHS）：制定并严格执行车间定期消杀计划，建立完善的防虫害（PCO）管理体系，有效预防和控制微生物及虫害污染风险，确保生产环境达标。
3. 体系文件与培训管理：负责厂务相关标准操作程序（SOP）及各类操作文件的制作、修改与升版；制定并落实厂务团队及车间人员的培训计划，确保全员熟练掌握相关操作规程及合规要求。
4. 合规与资质管理：深入理解并严格执行 FDA（美国食品药品监督管理局）、GMP（药品生产质量管理规范）及 ISO 13485 医疗器械质量管理体系要求；主导或协助完成厂房设施、特种设备及公用系统的定期年审、年检工作，确保各项资质合法有效。
5. 团队与跨部门协同：负责厂务团队的日常管理、绩效考核与能力提升；配合质量、生产、研发等部门，推进新车间建设、设备验证（IQ/OQ/PQ）及工艺改进等项目。
二、任职要求
1. 教育背景：大专及以上学历，暖通、机电、制药工程、生物工程或相关专业优先。
2. 工作经验：具有 3 年以上医疗器械、制药或食品行业厂务管理经验，有同等岗位管理经验者优先。
3. 法规知识：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。
4. 专业技能：
* 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。
5. 综合素质：具备较强的组织协调能力、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。
三、加分项
* 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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