Our client, a global healthcare company is currently recruiting for a Senior MES Engineer to join their growing team in Westport, Co. Mayo.
Responsibilities (full job description available on request):
1. Design, create, write and/or make all required changes to MES Recipes, worksheets, equipment and material spec's including phase transition logic.
2. Design, create, write and execute, test and validation protocols, risk assessments, and system documentation.
3. Design, create, write and/or make all required changes to ensure cleaning, equipment and product procedures are aligned to MES processes and vice versa.
4. Provide training for all other site personnel on their related MES roles and arrange system access.
5. Participate in MES knowledge exchanges, MES Governance meetings, and manage issues, work-arounds and fixes identified.
6. Participate in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems.
7. Adhere to and support all EHS standards, procedures and policies.
Requirements:
8. A third-level qualification in manufacturing, engineering, or business discipline.
9. Minimum of 7 years relevant experience and previous experience leading multiple implementation projects.
10. Proficiency with MES application and configuration rules and requirements including interfacing (preferably POMSnet).
11. Experience of batch processing operations in an FDA/HPRA regulated industry.
12. Strong knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry.
13. SAP knowledge/experience in MM, PP and IM modules.