Collins McNicholas

MES Technician

MES Technician required on a start-up pharma project in Sligo.

Key Responsibilities include:

  • Continuously review and manage business risk associated with POMSnet system and recipes.
  • Continuously review and ensure all business processes, including SOPs, required to implement and manage POMSnet system changes and POMSnet recipe changes comply with current Safety, Quality and Information Technology policies.
  • Continuously review and ensure all documented policies, procedures and training plans required to implement and manage POMSnet system changes and POMSnet recipe changes comply with current Safety, Quality and Information Technology requirements.
  • Ensure the timely and compliant qualification of POMSnet recipes and upgrades aligned with business objectives.
  • Support SAP business system as local key user (LKU) for POMSnet and material queries.
  • Communicates project status by preparing standard status reports, and by participating in departmental and customer project status update meetings.
  • Resolves project/system/ recipe issues by working with team members, project customers, and others as appropriate.
  • Responsible for systems compliance with quality related SOP’s.
  • Promote a culture of perfect performance and right first time within their team.
  • Required to front audits by HPRA/FDA or Customers on MES.
  • Participate in MES knowledge exchange with GMES and other sites
  • Participate in GMES Technical Review Board (TRB) Meetings, and manage issues, workarounds and fixes identified.
  • Participate in projects from initiation to ensure MES system or hardware requirements are understood and taken into consideration.

Key requirements:

  • Degree: Relevant science/engineering or IT discipline
  • A minimum of three years’ experience in an FDA/ HPRA regulated industry.
  • A strong knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is required for this role. 
  • Experience in a direct supervisory is required.
  • A good knowledge of the POMSnet or other MES system is required for this role.
  • Experience of operating in a team environment with active participation in proactive improvement programs is required.             
  • Total combined minimum years of experience required three.

 

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For a confidential discussion and more information on the role, please contact Davin Ferguson on 0719140251 or email davin.ferguson@collinsmcnicholas.ie

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