Our client, a leading biopharmaceutical company, is keen to hire a MES Engineer (Senior) to join their growing team in Mayo on a 12-month contract. The MES Engineer will provide project management guidance and expertise to the MES function along with providing technical guidance and solutioning to other MES Engineers.
Key Responsibilities of a MES Engineer (Full description available upon request):
- 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.
- 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 cGMP requirements.
Ideal Background:
- Third Level qualification in suitable manufacturing, engineering or business course and/or suitable experience.
- A minimum of 7 years authoring experience and has led or was technical lead on multiple implementation projects.
- Be proficient 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.
- 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.
For a confidential discussion and more information on this Senior MES Engineer role, please contact Sarah Flynn.
sarah.flynn@collinsmcnicholas.ie
+353 719108060