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CQV Engineer

  1. Midlands (Ireland)
  1. Contract
Competitive
26554/NK
  1. Commisions, Qualification and Validation
Date Posted07 Apr 2021
CQV Engineer contract with Global Biotechnology Organisation in Ireland.  

Hours per week: 40 (Site based, not working from home).

Ireland is a hive of activity for the Life Sciences Industry at present with global Organisations investing heavily in New Facilities here. An opportunity has a risen to join a leading Bio-Pharmaceutical organisation on a 12 month contract basis.  


Duties:

The Validation Engineer will prepare the necessary documentation and monitor progress for technical projects across the organisation.  

Desired Experience:
  • Strong relevant experience working in a Validation role in the Pharmaceutical / Biotechnology industry.
  • Experience of upstream / downstream drug substance processes
Principle Responsibilities:
  • Validation documentation – drafting, reviewing and approving Validation documentation.
  • Document coordinator support for Project and Sustaining operations
  • Execute Temperature mapping studies for controlled temperature units and / or manufacturing areas.
  • Participate in Validation Risk Assessments to determine the level of testing required for new equipment
  • Support sustaining and project Validation activities across Bulk Drug Substance, Packaging and Laboratory areas.
  • Developing library of softcopy versions of all Validation test documentation
  • Supporting closeout of TrackWise actions for Validation team
  • Raising, supporting and resolving validation deviations as they occur.
  • Coordinating a Validation dashboard update for site management / leadership
  • Ensure Re-qualification and Periodic Review activities are completed in a timely manner
  • Provide support in areas of commissioning and qualification of mechanical, process, electrical, automation equipment and systems and performance test protocols.
  • Encourage and sustain a high safety culture and performance within the Validation teams. 
 If this role interests you, apply today! 

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

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