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Computer Systems Validation Engineer

  • Location:

    Cork

  • Contact email:

    Sheldut@sigmar.ie

  • Sector:

    Engineering

  • Contact phone:

    +35321235914

  • Job type:

    Full Time

  • Job ref:

    SHCSVZT0402

  • Salary:

    €50,000 - 60,000

  • Published:

    29 days ago

  • Contact email:

    Sheldut@sigmar.ie

Job description

About Your New Employer:

The Computer Systems Validation team is responsible for Computer System Validation of PC Controlled Instruments in the Quality Control Laboratories and production facilities of a large multi-national Biotech manufacturing facility in Cork. We are seeking an experienced and enthusiastic Computer System Validation Engineer to join our growing CSV team on a long-term contract basis.

 

About Your New Job:

  • Manage Computer System Validation projects from software install to business release
  • Generate computer system validation documentation in accordance with site procedures and GMP guidelines
  • Liaise with service providers to determine successful installation of instrument software and ensure correct configuration
  • Execute test scripts, analyze test results and determine the acceptability of results against pre-determined criteria
  • Work with the business to identify and implement procedural controls to mitigate issues found during testing
  • Initiate and implement Change Control activities in accordance with Quality Standards and Practices
  • Determine solutions or recommendations for changes and/or improvements
  • Follow all relevant Environmental, Health and Safety procedures and assist in incident investigations as required

What Skills You Need

  • Minimum 3-5 years’ experience validating IT applications e.g. requirements gathering, design documentation, test case development, system & acceptance testing
  • IT qualification would be an advantage but not required
  • Experience of server and workstation platforms and working in a Win 10 environment
  • Experience of SQL databases is an advantage
  • Experience of analyzing and challenging s/w to identify gaps.
  • Familiar with Annex 11/21CFR Part 11 requirements, GAMP 5 and data integrity guidelines
  • Experience of working in a pharmaceutical API manufacturing operation or a regulated environment is desirable.

What’s on Offer

  • Permanent position 
  • Excellent base salary

Given the current climate, Interviews will be conducted remotely via MS Teams.

What’s Next​

For a confidential discussion on this or any other current job opportunity please contact Sylvia Heldut on 087 709 43 55 / sheldut at sigmar.ie

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