天津招聘

职位描述：
SUMMARY

Full time maintenance for the equipment and facilities of the global-standard JHL Biotech facilities in Wuhan, China. This function is responsible for both the JHL-1 commercial facility and Development Laboratory:
? Active participation in the development and implementation of the Company Quality Management System with specific responsibility for facility systems and critical equipment: routine maintenance and response to breakdown maintenance.
? Member of the cross-functional Engineering and Validation Department.
? Management of JHL Maintenance personnel
? Ensuring the Company’s direct-impact equipment are maintained in a validated state.
? Management of specialist contractors and vendors to maintain equipment.
? First point of call for the Company’s facility systems including:
o Bioprocessing equipment, Process Development equipment
o HVAC (Classified Cleanrooms and general areas), Water for Injection systems
o Pure Steam Systems, Compressor Dry Air systems, Specialist gas systems
o Process Glycol, Chilled water system, Cooling water system, Boiler system
o Waste Water Treatment systems, Electrical power system (included emergency generator)

ESSENTIAL FUNCTIONS
Essential functions include, but are not limited to the following:
? Site Safety
o Developing and maintaining a culture of safe working practices through personal leadership and establishing standard procedures for safety management.
o Enforcing a system for job safety assessments and issuing permits-to-work including lock-out tag-out of energized and hazardous systems. Zero lost-time injuries
? Maintenance of Facility Systems
o Maintaining the operational state of facility systems incompliance with Good Manufacturing Practice (GMP).
o Preparing and managing the schedule of preventative maintenance activities for the site. Priority being core manufacturing facility and utilities and coordination with Production and QC departments.
o Coordination of specialist service providers and vendors to execute the maintenance program. Breakdown repair and trouble-shooting of equipment and facilities.
o On call (SMS) for emergency response to system alarms.
o Issue and management of Work Orders.
o Annual, half year, quarterly, monthly, weekly maintenance of facility systems.
o Managing the inventory of critical spare parts to ensure that foreseen mechanical failures of utilities can be rectified within 24 hours.
o Managing the programmed maintenance plan for the site covering cleaning and renovation of buildings and grounds to keep them in a high standard.
o Minor redesign and capital projects to improve operation status.
? Quality
o Preparing standard operating procedures and associated records for management and execution of the maintenance program.
o Raising and/or resolving investigations for quality incidents related to performance of facilities and equipment. Complying with, and continuously improving, the Company Quality Management System.
? Design
o Review and mark-up of design drawings to provide practical and easily maintained design. Recommend and approve preferred vendors for equipment and spares
o Selection of critical and routine maintenance spare parts such as gas filters, HEPA filters, motors, electrical components, and chemical dosing consumables.
? Management
o Preparing weekly and monthly progress reports. Management of Engineers and Technicians including setting objectives, working roster, and review of performance.
o Selection and supervision of specialist contractors and vendors.
o Providing technical and financial input to capital expenditure requests for site improvement and renovation projects.
o Approval of operating expenditure in line with approved budget and authority level.

JOB QUALIFICATIONS (EDUCATION, CERTIFICATIONS, EXPERIENCE)
o B.E. (preferably Mechanical or Electrical) plus a minimum of 5 years responsibility facility systems within pharmaceutical organization, or at least 8 year facility maintenance experience in healthcare, specialty chemicals, or food industries.
o Detailed knowledge and hands-on experience in maintenance of facility systems.
o Preferably experienced in operation of biopharmaceutical API facilities and exposure to facility start-up. Preferably member of ISPE, ASHRAE, and/or ASME.
o Demonstrated experience in management of high-performance teams
? OTHER KNOWLEDGE AND SKILLS REQUIRED:
o Sound knowledge of Good Engineering Practices (GEP) encompassing documentation and equipment selection for pharmaceutical facilities. Sound Understanding of Good Manufacturing Practice (GMP)
o Experienced in operation and optimization of facility systems.
o Hands-on experienced in knowledge maintenance of pharmaceutical utility systems (e.g. PW, WFI, Pure Steam, Compressed Air, and HVAC) and general building services (e.g. access control, boiler, waste neutralization, chillers, cooling towers, electrical power, emergency generators, compressed gas)
o Certified boiler attendant, Qualified in CPR.
o Stand by on holiday and night shifts. 24hours 365 days operation facility system.
o Experience with central facility monitoring systems (BMS)
o Hands-on Manager/Super-user experience with a Computerized Maintenance Management Systems (CMMS) such as Blue Mountain.
o Familiar with calibration of automated systems including SCADA, DCS, and PLC- based systems. Ability to investigate and solve detailed technical problems.
o Advanced document writing skills using MS Office suite.
o Eye for detail and preference to work in highly structured manner.
o Strong communication skills in English and Chinese to engage with personnel across the Company and service providers including understanding of technical documentation in English. 举报 分享

    喜康生物由凯鹏华盈、红杉资本、柏乐创投、台湾中华开发工业银行率先出资建立。在喜康生物成立后的第二年，即2014年，台湾统一集团、富邦投资等台湾多家财团继续跟进投资完成B轮近3500万美元的融资。2015年3月，喜康生物完成C轮增资，本次募资金额达4560万美元，投资者包括管理资产额超过1.6万亿美元的全球知名的交叉基金麦顿投资、元生创投和利域投资管理公司。公司自成立以来，已成功募集超过1.35亿美元资金。2015年9月，喜康生物成功登录台湾资本市场。2016年2月25日，喜康与美国通用合作建立的全球首个符合国际标准的模块化大分子生物制药工厂（KUBioTM）建成并正式投入运营。2016年12月份，法国赛诺菲与喜康生物达成战略合作伙伴关系。
    公司主营业务是为国际国内医药企业提供抗体药物研发及生产代工服务。成套引进国际抗体生产设备和质量管理体系，实现美国FDA和欧盟EMA标准认证。公司定位于治疗性抗体药物研发和产业化转化，为国际国内客户提供抗体工程细胞株筛选、培养基培养工艺优化、纯化制备工艺优化、工艺放大、质量研究和质量标准制定、临床前、临床研究样品制备及终端上市产品的生产、符合美国和欧盟的质量管理体系等内容的合同外包服务。
    喜康（武汉）生物医药有限公司的核心技术团队均来源于基因泰克（Genentech）、罗氏（Roche）以及辉瑞（Pfizer）等全球***生物医药领军企业服务背景，曾领导了多个重磅生物抗体药的研发与生产，尤其在抗体药大规模生产技术方面积累了领先于行业的宝贵经验。
    喜康生物目前在台湾新竹建设有符合国际标准的抗体药物研发及中式基地。2016年2月位于武汉光谷生物城的符合国际标准的模块化大分子生物制药工厂正式投入运营。喜康生物研发及生产的rituximab生物类似药（学名中译：利妥昔单抗）于2016年2月获得英国药监局核准，将在欧洲进行用于类风湿性关节炎病人之临床一期试验，成为一家获准在欧洲进行单克隆抗体生物类似药临床试验的生物制药公司。
    2013年9月25日，美国通用电气（GE）正式在全球新闻发布，将为JHL公司在中国光谷生物城建设KUBio模块化生物制药工厂。KUBio不同于中国传统的生物制品厂的建设，它是一种建设生物制药工厂的全新方法，可在14-18个月内为客户提供功能齐全，可直接投入生产的生物制药工厂，相对于传统工厂，大大缩短了建设周期。KUBio 完全按照cGMP的验证要求设计，能帮助生物医药生产商迅速应对当地医疗需求，将能够挽救生命的药品推向市场。KUBio采用集成模块技术，其所有核心厂房的建设，装修，设备，均在德国建设完毕，然后运抵光谷生物城现场进行安装。
    JHL的cGMP标准生产车间将通过美国及欧盟认证，生产工艺将达到国际领先水准，成为一家可以为全球生物制药合作伙伴提供完整解决方案的供应商。