IT MES Analyst

  • Type: Permanent
  • Location: Limerick
  • Salary: Negotiable
  • Job Ref: ITM140917
  • Date Posted September 14, 2017

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.

More Details

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.

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