Job Title: Manufacturing Systems Specialist
As a key member of our team, you will be responsible for maintaining the MES environment at our Westport site. This includes designing and creating protocols, risk assessments, and system documentation.
You will also be responsible for ensuring that cleaning, equipment, and product procedures are aligned to MES processes and vice versa. Additionally, you will provide training for all other site personnel on their related MES roles and arrange system access.
Other key responsibilities include participating in MES knowledge exchanges, liaising with the Global MES on Westport for system improvements, and managing issues, work-arounds, and fixes identified.
* Design and create MES Recipes, worksheets, equipment and material spec's including phase transition logic
* Design and create test and validation protocols, risk assessments, and system documentation
* Ensure cleaning, equipment and product procedures are aligned to MES processes and vice versa
* Provide training for all other site personnel on their related MES roles and arrange system access
* Liaise with the Global MES on Westport for system improvements
This role requires a strong knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry, as well as experience of batch processing operations in an FDA/HPRA regulated industry.
A good knowledge of IT systems is also required for this role, and SAP knowledge/experience in MM, PP and IM modules is an advantage.
Requirements:
* Third Level qualification in suitable manufacturing or engineering course and/or suitable experience
* A minimum of 2 years authoring 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
* Good knowledge of IT systems
* SAP knowledge/experience in MM, PP and IM modules an advantage