
Senior System Engineer - POMS MES
- Westport, Co Mayo
- Permanent
- Full-time
- Senior System Engineer - POMS MES
- Onsite role
- County Mayo
- Permanent or Contractor Opportunity
- 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.
- 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.