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IT Labs Systems Engineer 1468

Waterford  

About SimoTech

SimoTech provides manufacturing automation and IT systems engineering, project management and validation services. We partner with life sciences companies to design, build, operate and optimise critical process automation systems that deliver fast track project delivery, operational efficiency, improve manufacturing agility and achieve regulatory compliance.
 

Why SimoTech

What is it like to work at SimoTech? With a strong collaborative teamwork culture based on respect, trust and excellence, we play a critical partnering role to our clients’ life-changing supply of products to patients. In return, there is excellent salary, career progression, educational support and much more.
 

IT Labs Systems Engineer 1468

SimoTech requires an IT Laboratory Systems Engineer to support our client, a large biopharmaceutical manufacturer in Waterford. The IT Laboratory Systems Engineer will be responsible for operational support, ensuring reliable, robust, and compliant Laboratory IT systems to meet business requirements, including the integration of benchtop analytical equipment to these systems.



Key Responsibilities

  • Configuration and administration of laboratory, quality and validation systems and applications. 
  • Work on networking, hardware, databases, and operating systems for equipment installations and maintenance.
  • Ensure that systems are robust, reliable, and available to meet business demand.
  • Establish plans for system maintenance in a compliant manner, according to the IS quality system.
  • Undertake routine actions such as folder creation, backups and restorations, account management, troubleshooting, and resolution of complex issues in GMP and non-GMP laboratory environments.
  • Ensure systems have suitable disaster recovery plans and procedures including contingency plans.
  • Proactively work with Quality and Laboratory teams to encourage the use of technology to maximise efficiency, capacity, and reliability of operations.
  • Ensure scheduled calibrations/qualifications are performed to include annual PM, OQ (Operational Qualification) and PQ (Performance Qualification).
  • Coordinate with relevant corporate business and IS teams to ensure that IS strategy for quality and laboratory systems is aligned with client goals and standards.


Qualifications

  • Bachelors or Master’s degree in Engineering, Information Systems, Computer Science, or the Life Sciences.
  • At least 3 years’ experience providing Lab IT systems solutions and support to manufacturing organisations in the biotechnology or pharmaceutical industries.
  • Experience with the following systems would be an advantage: Chromatography, Lab Data Archival, Electronic Methods Execution/Electronic Lab Notebook, LIMS, or Environmental Monitoring.
  • Knowledge of databases, reporting and analytic systems.
  • Thorough knowledge of pharmaceutical industry regulations (cGMP/cGLP) required. 
  • Good working knowledge of 21 CFR 11 compliance requirements as they relate to Lab IT systems.


What SimoTech Can Offer

  • Role provides a high degree of autonomy to allow the successful candidate to reach their full potential.
  • Develop new skills and enhance technical ability by working with innovative technologies in a multi-disciplined environment.
  • Opportunity to work with large corporate clients on exciting capital projects.


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