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CQV Engineer

  1. Ireland, West
Ireland
  1. Contract
Competitive
  1. CAPEX Projects
36446
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CQV Engineer -  Ireland - 12 Months Contract 

We are recruiting on behalf of a leading global pharmaceutical client based in the surroundings of Ireland. Due to a large capital investment and multiple projects on site, the client is looking for a CQV Engineer to join their team.

Responsibilities include:
  • CQV documentation – drafting, reviewing and approving CQV documentation
  • Oversight of the Commissioning, Qualification, Validation of specific equipment, ensuring all projects are on schedule and meet the set time-lines.
  • Provide guidance / expertise in one or more of the following equipment / areas : Clean Utilities, HVAC, Media Preparation, Buffer Preparation, Process Equipment, QC Equipment and instruments.
  • Support ongoing HVAC re-qualification and new facility qualification
  • Oversee the start-up and commissioning of new equipment within the Packaging, BDS and Warehouse areas.
  • Experience in System Start up, Commissioning, Functional Testing & Qualification necessary, including safe systems of work
  • Accountable for ensuring activities are scheduled, tracked, and reported appropriately, and achieving project deadlines.
  • Support the ongoing site re-qualification program
  • Risk assessments, root cause analysis and investigations.
  • Review of protocols, reports, project change controls and deviations.
  • Understanding and applying industry specific compliance standards/regulations to all CQV activities.
  • Generation and review of protocols, reports, project change controls and deviations.
Key requirements include:
  • Commissioning, qualification and validation experience in Pharma or Biopharma Manufacturing Facility 
  • Relevant experience as subject matter expert / engineer in a high-tech industry such as Biotech or Pharma, preferable
  • 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 HVAC qualification/re-qualification desirable.
  • Excellent technical abilities with a solid base in engineering.
  • Strong technical writing and communication skills.
  • Proven track record in generation of validation/verification documentation.
  • Technical diploma or Degree in Engineering/Life Sciences or greater preferred.
If you are local to Ireland and interested in discussing this position, please submit your profile and we will be in contact at our earliest convenience.

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