Our multi-national client is currently recruiting for an experienced IT MES Analyst for a permanent position within the Pharmaceutical industry in Limerick.
The successful candidate will be responsible for the overall system maintenance and on-going support of the Manufacturing Execution Systems (MES). The individual provides MES configuration and support services to meet end-user needs. Additionally, the individual processes system change controls, documents and maintains configurations to ensure that the MES remains in a validated state.
• Provides MES configuration & support services to meet end-user needs.
• Processes system change control, documents configuration, and writes test plans to ensure that the MES remains in a validated state.
• Coordinates the needs of functional departments & establishes priorities for MES requirements gathering, system design & implementation.
• Responsible for maintaining MES design documentation in a state compliant to GAMP 5 throughout the system’s life cycle, including User Requirement Specifications, Functionality Specifications, and Configuration Specifications.
• Reviews company documentation including SOPs, Batch Sheets and/or Manufacturing Records to assess impact to MES related IT infrastructure and processes.
• Works with Validation and Quality Assurance departments to ensure MES is implemented following development life cycle approach.
• Provides end-user support for the MES including troubleshooting problems at the application server level.
• Performs User Management and system administration functions in MES.
• Recommends and installs systems updates, patches, services packs, and hot fixes.
• Monitors applications for readiness, availability, and performance trend analysis.
• Maintains disaster recovery environment and ensure periodic testing is performed.
• Logs application support incidents and prepares appropriate resolution plans.
Skills & Experience:
• BS/BA in computer science required with 5+ years of experience working within a life sciences manufacturing environment. Will substitute relevant industry experience for educational requirement.
• Knowledge & experience of Werum PAS/X would be a nice to have.
• In depth knowledge of concepts of GMP, ICH guidelines & GAMP requirements
• Knowledge of BioPharma business processes is desired.
• Knowledge of SQL, Oracle & relational database concepts.
• Logical troubleshooting & problem solving skills.
• Excellent analytical, written and oral communication skills