Our client, a leading pharmaceutical company based in Limerick are currently recruiting for an IT MES Analyst to join their team. This is a full-time, permanent position offering an excellent salary and benefits package.
Summary: 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.
Essential Duties and Responsibilities:
Provides MES configuration and 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 and establishes priorities for MES requirements gathering, system design and 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.
Education and 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 and experience of Werum PAS/X.
In depth knowledge of concepts of GMP, ICH guidelines and GAMP requirements
Knowledge of BioPharma business processes is desired
Knowledge of SQL, Oracle and relational database concepts;
Logical troubleshooting and problem solving skills.
Excellent analytical, written and oral communication skills
For more information please call Rachael O’Rourke on 061 336 136. Alternatively apply online now and a member of the Harmonics team will be in touch.