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Computer Systems Validation Engineer 1183

Cork  

JOB DESCRIPTION

SimoTech currently requires a Computer Systems Validation Engineer for a Pharmaceutical client based in Cork. This candidate will be part of a small team providing support to Automation, Process and IT Departments on site.



Key Responsibilities

  • Maintenance of all aspects GMP/CSQ compliance for the area(s) of responsibility.
  • Provide guidance, review and approval for all computer related validation documentation.
  • Ensure all QA personnel across the organisation are trained on all relevant aspects of computer system quality.
  • Ensure current quality procedures and standards are adhered to.
  • Report and escalate critical quality issues to the appropriate level of quality management for final resolution.
  • Lead site computer system maintenance activities and compliance of computer system validation/maintenance activities.
  • Ensure compliance with periodic review, change control, deviation, back up and archive, security and other support processes for systems.


Qualifications

  • Bachelor’s in, Engineering or related discipline.
  • 3+ years’ experience in CSV, QA/QC or related role.
  • Good understanding of Automation Systems.
  • Experience working in Life Sciences industry.
  • Understanding of Data Integrity.
  • Experience in Stakeholder Management.
  • Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration.
  • Team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.


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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