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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.
- 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
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.
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