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Laboratory Systems IT Engineer

  1. Ireland, Midlands (Ireland)
County Offaly
  1. Contract
Competitive
  1. Life Sciences
36002
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Laboratory Systems IT Engineer - Pharmaceuticals - 12-Month Contract

Are you local to Ireland and looking for your next contract assignment? Our client, a leading pharmaceutical organisation, are recruiting for a Laboratory Systems IT Engineer to join their newly assembled team and help contribute towards the development of their next core projects.  


Essential Duties and Responsibilities
  • Ownership and administration of the IS aspects of Lab equipment – including analytical equipment platform architecture, system ownership and lifecycle management. 
  • Provide effective communication and play a leading role in project management interaction with internal and external clients such as Quality Assurance, Regulatory Affairs, and QC analytical personnel.
  • Lead and support system improvements, development of detailed specification and standard operating procedures.
  • Ensure reliable, consistent & compliant operation of Lab EquipmentInstruments to meet the GMP and business requirements of the labs.
  • Lead technical root cause analysis, incident investigations and troubleshooting issues related to the Quality and Laboratory information systems.
  • Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
  • Participate in Computer Software Validations and protocolscript writing.
  • Support new technology introductions by performing IS assessments and implementing IS system configuration changes.
  • Solving complex problems, project management, lifecycle management and operational excellence.


Requirements
  • Experience with LIMS and Empower is desirable.
  • Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals; ICH and GMP guidelines desirable in relation to Lab IT requirements.
  • Experience with regulatory/customer audits is desirable.
  • At least 3 years’ experience supporting Quality and/or Laboratory information systems in the biotechnology or pharmaceutical industries or has worked in similar Laboratory environments and has gained expertise in the use of Laboratory information systems.
  • Experience with Empower CDS,  Sample Manager LIMS, Laboratory Analytical Equipment and instruments will be an advantage.
    • Candidates must have a working knowledge of the GAMP software development lifecycle.
    • Experience with facility start-up projects (brown field or green field) is desirable.
    • Experience in Training of personnel.
    • Previous experience in a Quality Control/GMP environment is required.
  • Experience with Microsoft Word, Excel, Powerpoint, Visio, and Project is required.
  • Knowledge of analytical testing in support of biopharmaceutical manufacturing is preferred but not required.
  • Ability to master, with minimal support, new IS technologies and processes
  • Strong knowledge of databases, reporting and analytic systems
  • Ability to ensure compliance with practices, policies, procedures, legal requirements and site objectives and goals
  • University degree in related science/IT/quality discipline required.

If this role is of interest to you, please apply now! 


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