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Automation MES Manager

Switzerland, Switzerland

  • Salary: Dependent on Experience
  • Job type: Interim/Contract
  • Posted: 16/11/2018
  • Contact name: Christopher Wise
  • Contact number: 01892 612612
  • Ref: 3768

Job description

1 year contract in South-West Switzerland with option to extend

Job Summary (Primary function)
The Automation MES Lead is responsible to develop, validate and support all the activities linked to the implementation of a Manufacturing Execution System (MES) for the new Manufacturing site.


Essential Functions of the Job (Key responsibilities)
Define a complete and detailed user requirement in collaboration with the key users
Follow up that all the tasks are performed on time with the appropriate level of quality by the local and external team
Ensure that the MES is configured in order to cover the data integrity requirement
Guarantee that all the validation is performed accordingly to the guidance and maintain this validation status among the time
Ensure that the system cover the user requirement defined at the beginning of the project
Ensure that the project is roll-out within the budget agreed
Ensure that MES is well interfaced with other systems
Ensure that all the SOP are created on time, with the appropriate level of detail
Provide the training material at least for the key users
Create and manage all the access and all the change request
Provide expertise and support to the different department whenever needed
Participate or lead to improvement project linked to MES
Ensure that the MES is maintained according to the procedure and that the periodic review is done as defined
Ensure that the system is ready for inspection at any time and provide support during inspections
Contribute positively to a strong culture of business integrity and ethics
Act within compliance and legal requirements as well as within company guidelines

 

Qualifications (Minimal acceptable level of education, work experience, and competency)
Must have at least 5 years’ experience working with automated system
Must have at least 3 years of experience in Biotechnology industries
Very good knowledge in Data integrity and Computerized system validation
Very good knowledge in GAMP (Good Automated Manufacturing Practices) and Commission & Qualification system
Knowledge in Data Historian