High-Level Technical Expert for Manufacturing Execution Systems
Job Description:
The role of a Senior MES Engineer is to ensure the efficient operation and maintenance of the manufacturing execution system. This involves designing, creating, and implementing recipes, worksheets, equipment, and material specifications, as well as phase transition logic.
In addition, this position requires the ability to design, create, write, and execute test protocols, risk assessments, and system documentation.
This Senior MES Engineer will also be responsible for ensuring that cleaning, equipment, and product procedures are aligned with MES processes and vice versa.
Furthermore, they will provide training to other site personnel on their related MES roles and arrange system access.
Responsibilities include participating in MES knowledge exchanges, MES governance meetings, and managing issues, work-arounds, and fixes identified.
Liaising with the Global MES team on site-required system improvements is another key aspect of this role.
Additionally, providing support to other MES system users to ensure business continuity is essential.
This Senior MES Engineer will participate in NPI projects from initiation to ensure MES system or hardware requirements are taken into consideration.
Maintaining up-to-date information on MES changes and documenting all activities in line with cGMP requirements are also critical tasks.
Cross-training within the team and training of new team members will be required.
Lastly, participation in continuous improvement programs to implement improvements in quality, safety, environmental, and production systems will be necessary.
Key Performance Indicators (KPIs):
* Successful implementation of MES system updates and enhancements
* Effective training of site personnel on MES roles and procedures
* Timely resolution of MES-related issues and incidents
* Continuous improvement of MES processes and procedures
Required Skills and Qualifications:
To be successful in this role, you will need to possess:
* A third-level qualification in a suitable manufacturing, engineering, or business course
* A minimum of 7 years' experience authoring MES systems, with experience leading or technical lead on multiple implementation projects
* Proficiency with MES application and configuration rules and requirements, including interfacing (preferably POMSnet)
* Experience of batch processing operations in an FDA/HPRA-regulated industry, with strong knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry
* A good knowledge of IT systems, including SAP knowledge/experience in MM, PP, and IM modules
* Proven attention to detail and mental concentration, to always ensure total compliance with procedures
Benefits:
This is an excellent opportunity to join a world-class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people's lives.
Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.
Others:
You will have the opportunity to work on challenging projects, develop your skills and expertise, and contribute to the success of the company.
Please note that this job description may be subject to change based on the needs of the company.