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Job Description
PE Global is recruiting a MES Engineer for a pharmaceutical client in Mayo, Ireland. The role involves maintaining the MES environment, authoring recipes, and providing technical guidance.
This is a 23-month contract with a pharmaceutical client in Mayo, Ireland.
MES Engineer Job Description
The MES Engineer will be responsible for:
- Maintaining the MES environment, including recipes and worksheets for the Westport site.
- Providing technical guidance and solutioning to other MES Engineers.
- Acting as a site escalation point for complex or challenging troubleshooting or recipe design.
- Providing project management guidance and expertise to the MES function.
The MES Engineer will be responsible for:
- Designing, creating, writing, and executing test and validation protocols, risk assessments, and system documentation.
- Designing, creating, writing, and making all required changes to ensure cleaning, equipment, and product procedures are aligned to MES processes.
- Designing, creating, writing, and providing training for all other site personnel on their related MES roles and arranging system access.
- Participating in MES knowledge exchanges, MES Governance meetings, and managing issues, work-arounds, and fixes identified.
The MES Engineer will also be responsible for:
- Liaising with Global MES on Westport required system improvements.
- Providing support to other MES system users as required to ensure business continuity.
- Participating in NPI projects from initiation to ensure MES system or hardware requirements are taken into consideration.
The MES Engineer will be required to:
- Keep other recipe authors up to date on MES changes.
- Document all activities in line with c GMP requirements.
- Cross train within the team and train new team members.
- Participate in continuous improvement programs to implement improvements in the quality, safety, environmental, and production systems.
The MES Engineer will be expected to:
- Adhere to and support all EHS standards, procedures, and policies.
Requirements
The MES Engineer will require:
- A Third Level qualification in a suitable manufacturing, engineering, or business course and/or suitable experience.
- A minimum of 2-5 years authoring experience and has led or was 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.
- Strong knowledge of c GMP and regulatory requirements relating to the pharmaceutical industry.
- A good knowledge of IT systems is required for this role.
- SAP knowledge/experience in MM, PP, and IM modules.
- Proven attention to detail and mental concentration, to always ensure total compliance with procedures.