- Reference: SJ47015
- Job Type: Contract
- Location: Sligo
- Category: Production
Our client based in Sligo require an MES Engineer for a 6 month fixed term contract.
- Troubleshoot and provide solutions for MES & SAP problems in recipe execution and recipe authoring.
- Liaise with QA to provide approved change control documentation for all MES system changes.
- Design, create, write and execute to a high quality standard, test and validation protocols, risk assessments, and system documentation.
- Design, create, write and/or make all required changes to MES & SAP Recipes, worksheets, equipment and material spec’s including phase transition logic to a high quality standard.
- Design, create, write and/or make all required changes to ensure cleaning, equipment and product procedures are aligned to MES processes and vice versa.
- Design, create, write and provide training for all other site personnel on their related MES roles and arrange system access.
- Participate in MES knowledge exchanges, MES Governance meetings, GMES Technical Review Board (TRB) Meetings, and manage issues, work-around and fixes identified.
- Work closely with IT regarding upgrades, patching, hardware support, security and system access.
- Liaise with Global MES on Sligo required system improvementsProvide support to other MES system users as required to ensure business continuity.
- Participate in NPI projects from initiation to ensure MES system or hardware requirements are taken into consideration.
- Ensure maintenance/replacement of MES hardware, scanners and bar-code labelers. Review for upgrades periodically.
- Keep other recipe authors up to date on MES changes
- Documentation of all activities in line with cGMP requirements.
- Cross training within the team and training of new team members
- Participation in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems.
- Adheres to and supports all EHS & E standards, procedures and policies.
- Diploma qualification in suitable science/engineering course and/or suitable experience.
- A minimum of 2 years experience in Batch processing operations in an FDA/ HPRA regulated industry. Strong knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is required.
- Experience in the operating in a highly automated environment and safe handling of dangerous chemicals is required for this role.
- A good knowledge of IT systems/MES (preferably POMSnet) is required for this role.
For a confidential discussion and more information on the role, please contact Aideen Cummins on 071-9140252 or email firstname.lastname@example.org
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