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Validation Engineer

  1. Midlands (Ireland)
  1. Contract
Competitive
26452/NK
  1. Commisions, Qualification and Validation
Date Posted30 Apr 2021
Validation Engineer - Global Biologics manufacturing facility -  County Westmeath

Dublin is a hive of activity for the Life Sciences Industry at present, with global organisations investing heavily in new facilities here. An excellent opportunity has arisen with one of the largest Biotech Manufacturing organisation in Ireland in the picturesque County Westmeath.

Duties: 

Syringe Filling Line CQV SME required to deliver Line upgrade to the Syringe format with the following scope of work:
  • Ownership of the Line Qualification Lifecycle document using Risk Based Verification Approach (ASTM E2500
  • Oversight/Execution of the vendor SAT testing and Execution of Verification Test Scrip
  • Oversight of the Vendor VHP CD/P
  • Oversight of the Autoclave sterilization cycle (Cycle Development and PQ) for the format contact part
  • Driving and execution of the Air Visualization Studies
Skills:    
  • Strong experince with Syringe Filling Line CQV
Qualification:
  • Understanding of the Risk-Based Qualification Approach, applied knowledge of ISPE C&Q and ASTM E250
  • Understanding of the Filling Isolator Concept
  • Hands-on experience with Installation and Verification test execution
  • Understanding of the Non-Touch-Transfer Technology
  • Understanding of the VHP Cycle Development and Performance Qualification
  • Understanding of the Autoclave Sterilization of the porous loads
  • Project Management Skills
  • Good Communication Skills
 
For more information on this position, please apply with your up to date CV today! 



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

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