- Reference: SJ45041
- Job Type: Permanent
- Location: Leitrim, Mayo, Sligo
- Category: Engineering, Technical & Manufacturing
In the role of MES Specialist, you will manage and implement manufacturing execution system (MES – POMSnet) changes and recipes to align with business objectives.
- Establish with the Manufacturing Manager the MES team goals, project plans and maintenance schedules
- Lead MES Technicians as required by the Manufacturing Manager
- Continuously review and manage business risk associated with MES system and recipes
- Continuously review and ensure all business processes, including SOPs, documented policies, procedures and training plans required to implement and manage MES system changes and MES recipe changes are in compliance with relevant systems
- Ensure the timely and compliant validation and qualification of MES recipes and upgrades aligned with business objectives
- Support SAP business system as local key user for MES and material queries
- Accountable to ensure to ensure that all MES related actions, CAPAs and projects are delivered on time, right first time as reflected by site performance targets.
- Responsible for systems compliance with quality related SOP’s
- Act as site representative for audits by HPRA/FDA or Customers on MES.
- 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.
Education & Experience:
- Degree in relevant engineering, science or related discipline
- 1+ year relevant MES experience
- 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 of operating in a team environment with active participation in proactive improvement programs is required
For a confidential discussion and more information on the role, please contact Aideen Cummins on 071-9140252 or email email@example.com
For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie
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