广东省数字贸易与服务公共服务平台

What can you expect from this role?

• Startup of new facility including installing, qualifying and maintaining Automation and controls system PLC/DCS/PI/MES.

-     perform all work safely and meet the requisite training requirements

-     Provide technical support to manufacturing and other departments for the design and operation of process automation equipment.

-     Provide troubleshooting and technical analyses on manufacture equipment and process automation system.

-     Act as control engineer for tech transfer of new process into the facilities.

-     Support production and project teams in questions of Automation and controls.

-     Create Automation related SOPs, Change control and deviation reports.

-     Support new project design, commission and validation.

•  Primarily responsible for the maintenance and administration of GMP automation systems for new facility. This includes DCS and vendor packaged PLCs.
•  Maintenance and operation of GMP automated systems such as bioreactors, centrifuges, purification skids, and utilities.
•  Be capable of troubleshooting issues related to equipment and automation systems independently.
•  Supporting evaluation of process discrepancies, developing corrective actions, and implementing corrective actions.
•  Perform commissioning and qualification activities for automation systems.
•  Perform CSV activities for the plant equipment on various control system e.g. time synchronization, disaster recovery, database backup, user access management, periodic review and etc.
•  Strong knowledge of Control Systems and Instrumentation and shall serve as a Subject
•  Matter Expert for process Risk Assessments and Hazards Analyses。
•  Collaborate with other functional teams such as Manufacturing, Quality, and other functions on cross-functional projects and responsibility e.g. Capable of leading continuous improvement projects and initiatives with involvement of other functional teams; directing the activities with external service vendor.
•  Adhere to the requirements specified in Automation related quality policies/quality standards or related SOP.
•  Adopt good engineering practice documents as guidance documents when performing the work function.
•  Provide 24x7 support when needed.
•  Implement, enforce and take ownership on all EHS Environmental, Health & Safety, requirements and initiatives within his/her areas of responsibilities.

What will you need to be successful?

• Bachelor degree from Automation/engineering/electrical engineering or equivalent degree and relevant work experience/training.
• Experienced in support, design and/or implementation of control systems and instrumentation, preferably in the biopharmaceutical or related industries.
• The candidate must have working experience with supporting or implementing projects on Control systems. Strong technical knowledge of Emerson Delta-V DCS or Siemens Building Automation System (BAS). 
• Strong technical knowledge of Siemens PLC and experience on PI/MES is preferred.
• Experience of Batch software and S88 Standard. 
• Experience on CSV activities on various control system
• Understand 21CFR requirement and participated on FAT/SAT/IQ/OQ for Automation control system
• Able to perform troubleshooting independently and resourceful to resolve plant equipment issue.
• Familiar with FlexFactory equipment Wave/SUB/Harvest/Viral/Chrome/Uniflux system will be advantage.
• Experience on 3rd party communication e.g. Profibus-DP, Modbus, OPC, Ethernet IP, etc. will be preferred.
• Candidate must be able to work well with others as a team member in an informal results oriented work environment.
• Must have good communication skills (both verbal and written) in English, and be able to work collaboratively with other groups 
• Candidate should have a good understanding of Good Manufacturing Practice (cGMP), particularly as they relate to the operation, validation and maintenance of computer controlled systems. 
• Knowledge of biological pharmaceutical production is desirable.

龙沙（中国）投资有限公司成立于2003年9月，是瑞士龙沙集团全资在广州设立的投资性公司。公司旨在于医药、化工及生命科学领域进行投资和再投资，同时提供以下服务：

-协助或代理龙沙所投资企业的货物及设备采购业务，并在国内外市场销售他们的产品；

-为龙沙所投资企业提供售后服务、技术支持及人力资源服务；

-为投资者提供咨询服务并为龙沙的关联公司提供市场信息、投资政策等咨询服务。