Senior CSV Engineer

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  • Job type:

    Full Time

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  • Published:

    4 days ago

  • Contact email:

  • Consultant:

    Loren Pey

Job description

About Your New Employer

  • Our Client, a world leader in delivering digital transformation solutions to Life Sciences. Through their knowledge and expertise in Automation, MES & Digital, they deliver stable manufacturing systems that are optimised to improve operational efficiencies, whilst maintaining compliance. 
  • The companies specialist engineering teams have the aptitude to deliver and support Pharma 4.0 architectures and solutions, covering all IT, OT and IoT applications, infrastructures and services.
  • Our client maintains a Managed Service on the site, supporting Automation, MED, IT functions acorss operational and project levels. 

About Your New Role 

  • You will manage Computer System Validation projects from software install to business release
  • You will be required to generate computer system validation documentation in accordance with site procedures and GMP guidelines
  • You will 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
  • Your role will involve you initiating and implementing 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
  • Past proven experience engaging business users to ensure that appropriate business needs are clearly defined, communicated and delivered at or above expectations
  • Strong oral and written communication skills are required, with proven ability to communicate and build relationships cross-functionally
  • Experience of server and workstation platforms and working in a Win 10 environment
  • Experience of SQL databases is an advantage
  • 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

  • Competitive Salary DOE
  • Healthcare 
  • Hourly Rate Optional 
  • Pension

What’s Next​

For a confidential discussion on this or any other current job opportunity please contact Loren Pey on 021 4847137 / lpey at

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