-
Job Description
Seeking a skilled MES Engineer to maintain the MES environment, author and maintain recipes & worksheets, and troubleshoot MES and SAP problems in recipe execution and authoring.
This is an excellent opportunity to join a world-class manufacturing operation with a strong culture of continuous improvement and innovation. The company is developing the capability to produce all its medicines, ensuring continuity of supply as they expand internationally.
Key responsibilities include:
- 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
- Participate in MES knowledge exchanges, MES Governance meetings and manage issues, work-arounds and fixes identified
- Liaise with the Global MES on the sites required system improvements
- 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 c GMP requirements
- Cross training within the team and training of new team members
- Participation in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems
- Adheres to and supports all EHS standards, procedures and policies
Requirements include:
- Third Level qualification in suitable manufacturing, engineering or business course and/or suitable experience
- A minimum of 2 years authoring experience preferably using POMSnet
- Be familiar 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 c GMP and regulatory requirements relating to the pharmaceutical industry
- A good knowledge of IT systems is required for this role