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CQV Engineer (Packaging)

  1. NI & Ireland
  1. Contract
Competitive
24107/NK
  1. Commisions, Qualification and Validation
Date Posted29 Jan 2020
As Dublin continues to embed itself as Irelands Pharmaceutical capital, we are seeking a CQV Packaging Engineer to become part of a $500 million state of the art bio facility.

Located 15 minutes from Dublin Airport and just a short distance from the lively, vibrant, and cultural Irish capital, this leading biopharmaceutical organisation leads the way with state of the art technology on their one of a kind manufacturing facility. 

While the role will primarily support the packaging plant there may be an opportunity to work within the Bulk Drug Substance facility also

Essential Duties and Responsibilities for this CQV role include, but are not limited to, the following:
  • Ensuring adherence to CQV procedures during the CQV execution phase
  • Support CQV leads with matters relating to Commissioning Engineering Change Control.
  • Generate, Execute, Review and Approve CQV documentation as necessary Liaise with CQV area leads, Quality and Design SMEs on preparation and execution of significant deviations.
  • Carry out regular Audits on all matters relating to CQV Verification documentation execution.
  • Execute technical and GDP review on executed Commissioning Verification documentation.
  • Creation & agreement of dry-run examples of executed CQV VTSs.
  • Understanding and applying industry specific compliance standards/regulations to all CQV activities.
  • Leading Risk assessments, root cause analysis and investigations.
  • Review of protocols, reports, project change controls and deviations.
  • Proactively highlighting any issues around compliance.
Desirable Experience:

  • Commissioning, qualification and validation experience and / or Quality Assurance experience in a Packaging plant 
  • Experience in bioprocess manufacturing experience in an established biotech production operation.
  • Experience in issue description, root cause identification, technical/quality impact assessment & corrective action justification.
  • Experience in quality assurance environments, quality management systems and GMP change management processes and impact assessments would be an advantage.
  • Experience in IMB/FDA environment advantageous.
  • Good general knowledge on Quality, cGMPs, ICH and ISOStrong technical writing and communication skills.


To be considered for this position, please apply with a copy of your up to date CV! 



The candidate must have the rights to work in the location stated in the job advert.

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