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Engineer - GMP Operation & Maintenance
1.5-2万
人 · 本科 · 2年及以上工作经验 · 性别不限2024/12/23发布

龙东大道1100号

公司信息
上海罗氏制药有限公司上海总部

外资(欧美)/1000-5000人

该公司所有职位
职位描述
罗氏促进多元化、公平性和包容性,代表我们所服务的社区。在全球范围内处理医疗保健问题时,多元化是成功的关键因素。我们认为,包容性是理解人们不同医疗保健需求的关键。我们共同拥抱个性,共同抱持对卓越护理的热情。加入罗氏,每个声音都会得到重视。
职位
Primary Purpose of Job (Job Summary)
* Organize and coordinate the works assigned to his/her in the functional
section
* Assure safety, GEP (Good Engineering Practice), and cGMP (current Good
Manufacturing Practice) compliance within his/her responsible area and workplace
* Provide efficient and cost effective utility supply and engineering
maintenance services
* Set up and improve facilities management system
Principle Roles & Responsibilities / Accountabilities (Major functions of the
position)
Responsible system:
* GMP related Facilities & Utilities, such as, HVAC, BAS/BMS, clean room,
ambient room, cool room, cold room, freezing room, air locker, Purified Water,
Compressed Air and etc.
Responsibilities will include:
* Responsibilities to include hands-on involvement with the troubleshooting,
maintenance and operation of above-mentioned system. Set up maintenance task,
plan for these systems and coordinate year planned shut down for facility
maintenance.
* Evaluation of responsible equipment and system’s performance through
assessment of equipment and system logs, monitoring reports, and maintenance
program. Develop corrective measures to improve equipment operational
efficiency.
* Provide technical assistance to site operating groups through
investigations, equipment assessments, and design support.
* Develop and update equipment/systems preventative maintenance plan, and
order components/parts according maintenance plan.
* Perform and manage the maintenance contract and manage the service provider.
* Management of building and utility control systems to ensure response to
critical alarms in compliance with Maintenance and Quality Procedures. Evaluate
trends and establish corrective actions to avoid repeat events.
* Participate in the review of responsible equipment and system’s design,
changes including specification and drawing reviews.
* Responsible for the development and implementation of GMP Facilities &
Utilities system instrument calibration plan, room temperature and humidity,
pressure difference calibration plan, air volume balance testing, environmental
monitoring, etc.
Safety, Health & Environment:
* Ensure that all applicable Safety, Health & Environment requirements are
compliant to group policy and local legal requirements.
Quality and Compliance:
* Collaborate with site quality to make sure Right to operate through
compliant to all related regulatory requirements.
* Implement and apply the Roche Pharma Quality System.
General Customer Service:
* Identify the customers that are the recipient of the service delivered.
* Develop effective relationships with key customers in order to understand
their business and expectations.
* Deliver services according to established service level agreements.
* Seek feedback from customers and/or stakeholders on performance and ability
to meet expectations.
* Incorporate feedback:
* Takes accountability to balance customer expectations and value for Roche.
* Takes ownership for problem resolution and escalates as appropriate.
* Response to customer is timely and communication is efficient.
Qualification and Experience
Education/Qualifications:
* Have a bachelor degree in HVAC, machinery or automation (equivalent or
higher), and must have more than 2 years of facility technical service
experience in the pharmaceutical industry.
* English proficiency: Proficient in using English in writing work documents
Leadership Competencies:
* Must have excellent organizational, coordination, communication, teamwork
skills.
Job Required Competencies:
* Technical knowledge regarding the operation, preventative maintenance and
trouble-shooting of site utilities is required.
* Must have demonstrated ability to solve certain technical problems and
ability to work independently.
* Experience in equipment commissioning programs is required.
* Solid experience with manufacturing industry and support equipment is
essential; working knowledge of process control systems is required.
* Must have excellent organizational, communication and personal work
management.
我们是谁
在罗氏,来自100个国家的100,000名员工不断推动着健康医疗行业的进步。我们一同工作,使罗氏成为了世界领先的以研发为基础的健康医疗集团。我们的成功源于创新、求知和多元化,也源于我们把相互间的差异作为一种优势。为了革新医疗健康领域,罗氏设定了远大的计划,坚持学习和发展,并不断寻找与之志同道合的伙伴。
罗氏中国由制药和诊断两大业务领域组成,员工总数超过7000人。作为全球个体化医疗的领导者,罗氏制药和罗氏诊断均在中国建成了完整的价值产业链,包括研究、开发、生产、营销等环节。未来,上海将成为罗氏继巴塞尔和旧金山之后的第三大全球战略中心,而罗氏也将继续践行对中国的长期承诺,满足中国患者的未尽之需。
罗氏提供平等的职业发展机会。

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