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IT MES Analyst - Limerick

Job Category:
Analyst (Business/Systems)
Job Type:
Level of IT Experience:
5-10 Years
Salary Description:
Job Ref:

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.

Responsibilities include:
•    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

Contact Details:
Tel: 061209513
Contact: Keith Toomey

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