Job Overview
This is an exciting opportunity to join a state-of-the-art facility on the west coast of Ireland.
The company has invested heavily in research and development, with significant investment spent on discovering new medicines and developing scientific breakthroughs that change people's lives.
With over 50,000 employees worldwide, this organization continues to grow and expand its operations.
Responsibilities:
1. Develop MES Recipes, worksheets, equipment and material spec's including phase transition logic.
2. Create, write and execute test and validation protocols, risk assessments, and system documentation.
3. E nsure cleaning, equipment and product procedures are aligned to MES processes and vice versa.
4. Provide training for all site personnel on their related MES roles and arrange system access.
5. Participate in MES knowledge exchanges, Governance meetings, and manage issues, work-around and fixes identified.
6. Support other MES system users as required to ensure business continuity.
7. Ensure MES system or hardware requirements are taken into consideration in NPI projects from initiation.
8. Keep recipe authors up to date on MES changes.
9. Document all activities in line with cGMP requirements.
10. Cross train within the team and train new team members.
11. Participate in continuous improvement programs to implement improvements in quality, safety, environmental and production systems.
12. A dhere to and support EHS standards, procedures and policies.
Required Skills and Qualifications:
* Third Level qualification in manufacturing, engineering or business course and/or suitable experience.
* Authoring experience and technical lead on multiple implementation projects.
* Proficiency with MES application and configuration rules and requirements including interfacing (preferably POMSnet).
* Batch processing operations in an FDA/HPRA regulated industry.
* cGMP and regulatory requirements relating to the pharmaceutical industry.
* Good knowledge of IT systems.
* SAP knowledge/experience in MM, PP and IM modules.
* Proven attention to detail and mental concentration.
Benefits
Apply Now if you meet the qualifications for this role.