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Job Description
MES Automation Engineer
Maintain the MES (POMSnet) environment; to author and maintain recipes and worksheets for client site
Responsibilities
- 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, workarounds and fixes identified.
- Liaise with Abbvie Global MES on Westport 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 cGMP 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.
- Third Level qualification in suitable manufacturing, engineering or business course and/or suitable experience.
- 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.
- SAP knowledge/experience in MM, PP and IM modules.
- Proven attention to detail and mental concentration, to always ensure total compliance with procedures.