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Validation Engineer

Introduction


Are you ready to take the new challenge? If you want a real challenge with exciting responsibilities, keep reading, you might find it here.

For our client, global leader in biopharmaceuticals, we are looking for a Validation Engineer.


Company/Department


The Biologics Pilot Plant (BPP) is manufacturing biological Drug Substance for human use, and is a multiproduct facility, with several different products/manufacturing campaigns per year.

This project consists on managing equipment cleaning issues (visual non conformities and/or failed results), making quickly decision on production continuation with suitable documentation, including an impact assessment and afterwards a thorough root cause analysis, leading to the definition of a suitable CAPA Plan and implementation of it.

In parallel of that, the mission may include the contribution to equipment cleaning optimization and cleaning process simplification.


Function information


Your responsibilities will be:

  • Lead on deviations and investigations related to equipment cleaning by working with operators, production managers, validation team and QA
  • Drive the definition of suitable CAPAs linked to cleaning deviations and the implementation of them
  • Ensure any change needed in cleaning controlled documents (e.g.: review and optimization of cleaning check lists, procedures)
  • Contribute to the definition of the daily rouging management process
  • Contribute to Continuous improvement related to the equipment cleaning process, in collaboration with the BPP team.

Requirements


  • At least 7 year experience pharmaceutical manufacturing processes, especially biological processes
  • At least 1 year experience as an expert on deviations management and investigations methodology required
  • Experience with Equipment Cleaning, rouging treatment required
  • Excellent quality understanding in GMP-regulated environment
  • Good understanding of technical processes and automated systems may be a ‘plus’ for that mission
  • Leader, Team Player, and experienced to work interactively with various stakeholders
  • Organized and systematic mindset
  • Excellent communication skills, as interacting with different teams/stakeholders: operators, production managers, validation team, quality unit
  • Excellent time-management skills, and experienced to work pro-actively to achieve given milestones and objectives
  • Fluent in French and Good knowledge in English

Offer


Why work as a consultant for XPE Pharma & Science?

  • XPE is a part of Adecco, one of the Top 5 companies within the 'Great Place to Work' ranking
  • At XPE Pharma & Science you're not just a consultant, you are one of a kind. 
  • Our HR Talent Managers  value Talent and build client-focused solutions with that in mind. They are dedicated to help you boost your career. This by coaching sessions, development centers and performance reviews. 
  • Respect and professionalism are at the basis of our job.  We are willing to go the extra mile for and with you.

Information


Andrea Baetens

010 80 71 15


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