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Senior MES Engineer

Job description

Summary:

  • This candidate will be required to work closely with the MMDIT teams responsible for the full Automation and IT scope and with vendors / partners with responsibility for delivery of systems.   
  • Reporting to the Project MES Lead, specifically responsible for MES Systems. 

Responsibilities:

  • Partner with local project teams to deliver Automation and IT aspects of Laboratory capital projects.
  • Liaise with site AIT group to add input to site SOP’s for lab systems.
  • Author\Review\Approval of qualification documents for lab systems – RS, CS, RTM etc…
  • Work with site teams on generation of requirement and\or configuration specification and IOQ test protocols.
  • Participate in execution of IOQ protocols for lab analytical instruments where required.
  • Generate any automation change control documentation required for introducing new systems or modifying existing systems for the QO Lab.
  • Generate any risk assessment\variance documentation and interface with above site team to close out same.
  • Work closely with the QAIT function to ensure compliance with MSD Quality standards.
  • Interface with above site teams for deliverables of Enterprise systems such as Empower, NuGenisis, Acronis etc.
  • Ensures that SDLC is appropriately applied.

Qualifications:

  • Bachelor’s Degree in Engineering, Information Systems, Computer Science or the Life Sciences.
  • Fluent in English, written and verbal.
  • Minimum of 7-10 years’ experience in a similar MES role, ideally in the Pharmaceutical industry.
  • Experience in the commissioning and qualification of MES on site in a GMP manufacturing environment
  • Experience in MES-ERP integration design and qualification, implementation on a greenfield site will be advantageous.
  • Technical proficiency of MES applications (preference Werum PAS-X)

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