We are seeking a MES Engineer to join our team at a global healthcare company.
The successful candidate will be responsible for:
* Designing, creating, writing and/or making changes to MES Recipes, worksheets, equipment and material specs including phase transition logic
* Designing, creating, writing and executing test and validation protocols, risk assessments, and system documentation
* Ensuring cleaning, equipment and product procedures are aligned to MES processes
* Providing training for site personnel on their related MES roles and arranging system access
* Participating in MES knowledge exchanges, Governance meetings and managing issues, work-arounds and fixes identified
* Participating in NPI projects from initiation to ensure MES system or hardware requirements are considered
* Documenting all activities in line with cGMP requirements
Requirements include:
* A Third Level qualification in manufacturing, engineering or business discipline
* A minimum of 2 years experience preferably using POMSnet
* Familiarity 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
* SAP knowledge/experience in MM, PP, and IM modules is an advantage