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Job Description:

Our client, a BioTech multinational based in Limerick and an outstanding employer is currently looking for a QA VALIDATION TECHNICAL WRITER to join their team. This is a contract opportunity based in Limerick

You will be performing Document Preparation and Field Execution activities for Cleaning Validation of the BioTech facility.


Position Objective

  • Generate/review/Approval of protocols
  • Generate Reports
  • Maintain and update the Continuing Validation Plan and Continuing Schedule
  • Carry a number of CI (continuous process) within Continuing
  • Set-up systems for the Continuing program
  • Experience in Gowning for IOS7/ISO8
  • Generating and Executing Validation Protocols.
  • Follow all EHS/Safety SOP/Policies


Essential Duties and Responsibilities include:

  • Cert/Diploma/Degree in the Science/Engineering
  • At least 2-3 years’ experience as a Technical writer within the medical/pharma/biopharma company
  • 1-2 years’ experience in cleaning Validation
  • Experience in continuing Validation/re-validation
  • Experience in gap analysis assessments
  • Experience in Deviation/Change control writing
  • Experience in continuing assessments of equipment
  • Excellent people skills
  • Experience in Gowning forIOS7/ISO8
  • Project management skills along with the ability to manage a large programme
  • An understanding of how manufacturing/Cleaning Validation/HVAC/Cleaning equipment works would be of benefit
  • Experience in gap analysis assessments
  • Extensive experience on writing and approving Deviations
  • Technical writing experience has written a number of white papers and site reports 
  • Have Troubleshooting and analytical mind-set.




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Salary: Daily Rate
Recruitment Contact

Contact: Emilia Los

Telephone: 061209519


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