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CQV Engineer- Utilities

  1. Denmark
  1. Contract
Competitive
25784 JL
  1. Commisions, Qualification and Validation
Date Posted13 Nov 2020
 CQV Engineer- Utilities - Denmark

Bio pharmaceutical company require a Specialist Utility CQV Engineer to manage the utility systems (both grey and clean) for a new filling line project on a substantial biotechnology capital investment project (CAPEX), based in Denmark. 
 12-month contract initially - scope for extension beyond this.

Reporting to the CQV Lead, the successful Engineer will coordinate the delivery of varied utilities from design stage into operational handover on this greenfield project.
Responsibilities:
  •  Support the commissioning, qualification, and validation of all Utilities systems for a greenfield fill finish/drug product project. Including but not limited to; cooling, steam, compressed air, gasses, Clean Utility, PW water, clean steam, process air, clean gasses, WFI.
  • Review vendor documents to support commissioning and qualification requirements.
  • Completes the development, review, and execution of validation plans, URSs/DQ/FATs/SATs/IQ/OQ protocols/reports.
  • Ensures validation non-conformances or deviations are minimised during execution of CQV activities. For issues that do arise ensure they are closed out in a timely manner.
  • Supervise vendors/ contractors on site during commissioning activities.
  • Ensuring compliance with current industry regulations and guidelines relating to validation.
  • Support department performance against defined KPIs.
  • Encourage actively the culture of teamwork and integration within the Project matrix organisation, and with all other Departments.
  • Participate fully in cross-functional training initiatives.
  • Ensure timely completion of all SOP, reading, training and assessment.
  • Other duties as required and directed by the Project Manager or CQV Lead.
Requirements
  •  Extensive experience commissioning, qualification, and validation (CQV) experience within a complex project environment.
  • Extensive understanding and knowledge of Utilities Including but not limited to; cooling, steam, compressed air, gasses, Clean Utility, PW water, clean steam, process air, clean gasses, WFI.
  • Ideally this individual would have worked as part of a matrix organisation to deliver start-up projects.
  • Knowledge of validation practices and regulatory guidelines for a biopharma / pharmaceutical facility.
  • Experience with regulatory audits, in particular representing equipment qualification type issues.
  • Experience of writing validation plans, requirements gathering, design documentation, system configuration, system testing and troubleshooting


 If you are keen to be involved in one of Europe’s largest projects, please apply now with your CV highlighting relevant projects experience.





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