Validation Engineer

1 jour restant

Région
Braine-l'Alleud
Publication
jeudi 20 décembre 2018
Date limite
dimanche 20 janvier 2019
Réf
8534AXPE-BE
Contact
Andrea Baetens
Fonction
Autre
Niveau d'expérience
0 à 2 ans d'expérience
Type de contrat
CDI
Temps de travail
Temps plein
eXPErt services for eXPErt professionals.
That's XPE. For one of our clients we are looking for: Validation Engineer Organisation description:

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.

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.

Job description:

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.
Profile:
  • 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.


Licenses
XPE Personnel Services NV/SA: Flanders: VG15/BU, Brussels: B-AA5.031, Wallonia: W.RS.002/W.INT.002
XPE Group NV/SA : Flanders: VG1834/B, Brussels: B-AA11.007, Wallonia: W.RS.713

Emplois similaires

Emplois similaires