Engineering & Electronics

QA Validation Technical Writer

  • Contract
  • Limerick, County Limerick, Ireland
  • 42031181

The role:

PE Global is currently recruiting for numerous QA Cleaning Validation Engineers on behalf of a leading biotech company based in Limerick. This is an initial 12 month contract role.

 

Responsibilities:

  • Execution of cleaning validation protocols.
  • Taking Cleaning Validation samples alongside Upstream/Downstream processing.
  • Working closely with manufacturing to ensure the CIP/SIP and dirty holds are to the correct times and samples are taken.
  • Generate/review/Approval of CV protocols,
  • Generate Reports
  • Maintain and update Cleaning Validation Plan
  • Schedule of cleaning activities with Manufacturing
  • Liaise with numerous departments
  • Ensure Training is maintained and current.
  • Follow all EHS/Safety SOP/Policies
  • Actively look for Continuous improvements

 

Experience:

  • Experienced in QA Validation activities –
  • Extensive experience on writing and approving Deviations/GMP documents
  • Technical writing experience in writing site reports
  • Experience in aseptic technique
  • Experience in Gowning for IOS7/ISO8
  • Generating and Executing Validation Protocols.
  • Experience in Validation specifically cleaning validation
  • Experience in assessment of cleaning issues during study runs,
  • Experienced Technical writer,
  • Experience in Deviation/Change control writing,
  • Experienced in coverage testing and clean-into-service

 

 

Interested candidates should submit an updated CV.

 

Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net

 

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***