SKILLS BRIEF:

• Third Level qualification in suitable manufacturing, engineering or business course and/or suitable experience.
• A minimum of 5 years authoring experience using POMSnet.
• You must be able to provide evidence that you have led or were a technical lead on a number of key implementation projects.
• Be highly proficient with MES application and configuration rules and requirements including interfacing (preferably POMSnet).
• Experience of batch processing operations in an FDA/HPRA regulated industry. Strong knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry.
• A good knowledge of IT systems is required for this role.
• SAP knowledge/experience in MM, PP and IM modules is a requirement.
• Proven attention to detail and mental concentration, to ensure total compliance with procedures at all times.

THE ROLE:

• Senior System Engineer - POMS MES
• Onsite role
• County Mayo
• Permanent or Contractor Opportunity

ROLE BRIEF:

The successful candidate will be responsible for the maintenance or the Manufacturing Execution System (MES) environment. This is a POMSnet system and you will author and maintain recipes and worksheets for the manufacturing site using the POMSnet system.
You will also provide technical guidance and solutioning to other MES Engineers and act as site escalation point for complex or challenging troubleshooting or recipe design. Furthermore you will provide project management guidance and expertise to the overall MES function.

Core Tasks:

• Design, create, write and/or make all required changes to MES Recipes, worksheets, equipment and material spec’s including phase transition logic
• Design, create, write and execute, test and validation protocols, risk assessments, and system documentation.
• 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.
• Provide 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.
• Keep other recipe authors up to date on MES changes
• Documentation of all activities in line with cGMP requirements.
• Participation in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems.