- 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.
- 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.
- 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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