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Validation Engineer - Process & Cleaning - Biopharm

  1. Cork
  1. Contract
Competitive
23518WP
  1. Commisions, Qualification and Validation
Date Posted25 Sep 2019
Excellent opportunity for an experienced Process & Cleaning Validation Engineer to join one of Cork's expanding Biopharmaceutical projects.

Our Biotech facility based just outside of Cork is currently investing in their manufacturing programme & is proud to have a high score Glassdoor rating for its working environment! 

To be successful for this position we are looking for the following skills & experience  
  • Process Validation 
  • 5 yrs in a cGMP environment
  • Biopharmaceutical experience
  • Experience with Fed Batch equipment such as bioreactors, centrifuge, chromatography columns, UltraFiltration Diafiltration units
  • Experience in writing cleaning validation processes
 Responsibilities
  • Provide oversight for validation activities related to the process and cleaning validation activities
  • Developing validation plans and rationale for process and cleaning validation studies
  • Execute (protocol generation, execution, and final package preparation and reports) validation activities related to  process and cleaning.
  • Lead and represent Validation in multi-departmental meetings & project teams.
  • Coordinate validation activities involving cross-functional, multi-departmental teams including: Manufacturing, Process Sciences, Process Development, Quality Control, Quality Assurance, Regulatory Affairs, and others.
  • Identifies and implements improvements to the QA Validation systems
  • Participation in the change control program for modifications to qualified processes.
  • Establish Site Validation Policies, through development, generation and implementation of validation master plans, guideline documents and SOP’s.
Call me for more information on this long term contract role!

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