Automation MES Manager

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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