Automation MES Manager

Location
Switzerland
Salary
On Application
Posted
19 Nov 2018
Closes
19 Dec 2018
Ref
CWi
Discipline
Quality, QA / QC
Contract Type
Contract

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

 

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