Connecting...

Senior CSV Engineer

  • Location:

    Cork

  • Contact email:

    Lpey@sigmar.ie

  • Sector:

    Engineering

  • Contact phone:

    +35314744600

  • Job type:

    Full Time

  • Job ref:

    LPcsV67485

  • Salary:

    Negotiable

  • Published:

    4 days ago

  • Contact email:

    Lpey@sigmar.ie

  • 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 sigmar.ie

Why Apply Through Sigmar?

  • We’ll help manage your job hunt, strengthen your interview skills and tidy up your CV
  • We’ll provide you with an overview of the jobs market within your industry and help you tailor your jobs search
  • Gain access to exclusive roles that are not advertised elsewhere

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.