苏州招聘

职位描述：
Job Summary职位概述:
-Be responsible for Non GMP (black utility) system testing & commissioning & handover, supervise 3rd party service provider to work with AMF to ensure the final site handover on time / on scope / on budget
-Focus on Medical device or Phama Non GMP systems, equipment and buildings. Such as chilled water & chiller, hot water, plant compressed air& air compressor, cooling tower, natural gas, high/low voltage electricity, city water, WWT, fire fighting , plumbing, Non GMP HVAC, etc.
-Failure-free operation of Non-GMP Buildings and Equipment. Support governance of 3rd party service supplier in the respective area.
-The incumbent also will manage and operate the CAFM & ERP system, e.g. Speedikon & SAP

Main Tasks & Responsibilities主要工作职责 :
-Non GMP systems handover, turn over package (documentation) review, including design drawings, T&C documents, equipment manual, maintenance plan, spare parts list, etc.
-Related SOPs draft or review and make sure they are up to date always. Deliver training if required.
-T&C (testing and commissioning) activities supporting, be able to develop testing protocol independently and ability to lead the execution of any T&C.
-Supervise the 3rd party service provider operate and maintain black utility systems, ensure systems (equipment) are maintained in an appropriate way by following relevant procedures. Make sure systems and equipment being maintained in good status all the time.
-Supervising the outsourced building facility installation, commissioning, maintenance, and spare parts organization. Ensure providing a safe and reliable facility environment.
-Support that all facilities & equipment are a in good status and unscheduled downtimes are minimized. Support continuous improvement activities with proper methods.
-Support internal QA related processes, e.g. events / deviation / CAPA coordination, ECR handling.
-Support the financial process, e.g. budget periodical review, planned expense vs actual, invoice handling, yearly budget planning.
-Downtime and unplanned shutdown control, review any abnormal case with the 3rd party IFM provider.
-Calibration coordination and make sure instruments/equipment being calibrated appropriately by following Roche IMTE principles and relevant regulations.
-Lead deviation investigation if happens by using proper methodology, CAPA management and initiate change control if required.
-Take the internal auditor roles and responsibilities if required, report all the non-compliant issues and give related improvement action proposal and follow the actions afterwards.
-SHE compliance. Ensure personnel in the 3rd party service provider and external contractor get appropriate safety training. Keep a safe working environment always.
-Keep close contact with the 3rd party service provider, monthly review their performance.
-Lead and review the daily work of the 3rd party service provider, facilitate them to achieve SLA (service level agreement) and KPI.
-Workshops for black utility topics scheduling or hosting if required.
-Vendors and maintenance contracts management.

Basic Requirements of the Job基本任职资格:

Education& Qualifications教育背景与专业资格:

Bachelor or above education background, major in M & E engineering, environmental engineering, chemistry engineering or automation related.
Experience工作经验:
-Experience in Facility/utility Management
-Basic troubleshooting skill is required. Knowing FMEA.
-Knowledge of SAP PM BMS EMS skills is preferred
-5 years of FM(Facility management) experience
-Be familiar with general facility/utility/building operation and maintenance.
-Experience in HVAC, cold room, clean room and electricity operation& maintenance is preferred.
-Experience in energy management is preferred.
-Proven communication skill in cross function department and external relationship
-Proven ability to manage the assets and relevant operations
-Fluent language skills in English and Mandarin
-GMP sense, Pharm thinking, various ISO standards awareness.
-The incumbent must have experience in similar industries, e.g. Pharma or Medical devices with related laws & regulations approach to different standards, e.g. ISO13485 and GMP

Leadership Competencies领导能力：
-Open-minded and ready for change
-Cooperate and collaborate with business partners with good teamwork spirit
-Excellent communication, negotiation and interpersonal skills in English and Chinese
-Detail-oriented with good planning and organization skills
-Ability to present/demonstrate in front of a large group of people
Professional Competencies/skills专业能力/技能:
-Familiar with assets lifecycle management
-Familiar with mechanical and electrical principles
-Be able to understand English technical documents
-Strong sense for high standard ISO13485/GxP/5S 举报 分享

作为体外诊断的全球市场领导者，罗氏诊断致力于为全球实验室和医院提供创新型检测和技术，从而帮助医疗专业人士为患者做出正确的医疗决策。

罗氏诊断苏州是罗氏诊断全球在亚太地区建立的首个生产和研发基地，公司将为罗氏集团在中国及亚太地区取得快速成长奠定坚实的基础。其总投资额达4.5亿瑞士法郎，包括9座大楼，占地面积超过48,000平米。2018年10月29日，罗氏诊断产品（苏州）有限公司在园区正式开业。

我们倡导“以人为本”的管理理念，致力于为员工打造理想的工作场所。真诚、勇气、激情是罗氏的的价值观。

在罗氏，改善患者的生活是我们每天努力工作的初衷，个人价值的实现将会变得更有意义，通过与工作伙伴的共同努力，倾力造福患者。

在罗氏，你将拥有一份富有挑战性的工作，同时也能够在生活和职业之间找到一种健康的平衡。

在罗氏，职业发展将跨越职能和地域，我们坚信每一个你都有自己的潜力。

这不仅是一份工作，更是你新的起点！

罗氏诊断苏州，期待你的加入！