MES LEAD ANALYST

This position will have a significant role in the delivery of MES projects and post deployment support.

Primarily this person will be mainly responsible and accountable for the site MES implementation (PAS-X) in the areas of systems requirements, configuration, test execution, release for use and ongoing change management efforts. The MES Systems Analyst will ensure that the system meets user requirements during each Phase (READY, FIT, BUILD and RUN).

Role Responsibilities

Work closely with the Business Analyst to understand and ensure MES User Requirements are clear, concise and deliverable
Development of appropriate technical specifications which are part of the MES Application Lifecycle Management documentation as input to overall design and deliverables
Ensure all enterprise integration systems requirements are captured as appropriate
Responsible for ensuring core application system configuration aligns with Master Data standards
Responsible for review and approval of the MES Application Lifecycle Management documentation
Plan and perform system integration testing, end to end testing and UAT
Work closely with technical lead to support technical activities and build system knowledge
Provide support to the MES Computer Systems Validation team
Provide support of all MES applications including Development, QA and Production
Following the delivery of updates/patches scope and participate in acceptance testing
Transition during project to Operational Support after go live
Acts as second tier support for MES system application, enterprise integrations and peripherals (Printers and Scanners). Logs support incidents and prepares appropriate resolution plans
Fully participates and works as an integral member of the IM Applications function

Skills & Experience Required

Good verbal and written communication skills.
Good organizational skills.
Must have good interpersonal skills. Position will require a good deal of interdepartmental interaction and coordination.
Must possess a thorough understanding of GxPs, in addition to FDA and International requirements for computer validation and Part 11/Annex 11 requirements.
Must possess a thorough understanding of current industry guidance, including GAMP 5
Must have direct experience with computer validation and determining computer validation approach, including enterprise platforms systems as well as custom software projects.
Must have ability to comprehend technical information related to computer software, computer and network hardware, and the associated regulatory requirements relating to them.
Experience/Knowledge in ERP, LIMS, EDMS, QMS, MES (PAS-X).
Proficiency with MS Office applications (Word, Excel, Visio, Access, Project, Powerpoint).
Experience with HP ALM or equivalent software testing/requirements tools

Please forward all cv’s to alan@lcaconsulting.ie