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CSV Engineer

Job description

Leading pharmaceutical company is looking for a CSV Engineer on permanent basis. Reporting to the relevant Lead, this position will have a significant role in the validation of computerized system.

100% remote work initially but will be required onsite as time goes by.

Job Responsibilities

  • Developing and executes all validation deliverables 
  • Owning issues/deviations and driving them to resolution.
  • Leading testing efforts for small to medium sized projects.
  • Reviewing vendor protocols, test scripts, and traceability matrix.
  • Generating test scripts to meet the user requirements.
  • Interacting directly with project teams and the associated vendors.
  • Assessing the validation impact of changes made to qualified instruments.
  • Other duties as assigned.

 

Job Skills & Experience Required

  • 5+ years’ experience in Bio-Pharmaceutical 
  • Computer Science or Engineering/Science Degree is preferred.
  • Experience working in a QC Lab Environment.
  • A thorough understanding of GxPs, in addition to FDA and International requirements for computer validation and Part 11 / Annex 11 requirements.
  • A thorough understanding of current industry guidance, including GAMP 5
  • Direct experience with computer validation and determining computer validation approach.
  • Experience/Knowledge in qualifying DeltaV, OSI PI, Serialisation changes.
  • Experience with HP ALM or equivalent software testing/requirements tools.

 

For a confidential discussion on this or any other current job opportunity please contact Marcel Skolimowski on 021 4847 138 / marcel@sigmar.ie

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