Nalys is a consulting group dedicated to high technology projects.
Thanks to our strong corporate values and adhocracy management, we are one of the fastest growing actors in engineering consultancy.
We gather great minds & challenge boundaries to help our customers develop stunning products. And we love doing it.
Discover how we can give a sense to your passion on www.nalys-group.com
About the job
Mission: You will be part of a worldwide project, supervised by a global team mainly based at the Lessines plant, Belgium (Center Of Expertise).
This team consists of Analysts, Validation Engineers, Technical Engineers and XFP developers. They drive the system design, development, installation,
validation, support and maintenance. Electronic Batch Management (EBM) is a divisional initiative for deploying a MES (Manufacturing Execution System)
olution based on the Siemens XFP software across our client's facilities (Europe, US and Singapore). To help our client facing the increased number
f projects and reinforce standards across facilities, Nalys is looking for a Global EBM Validation Engineer. You will lead and coordinate
qualification / validation activities linked to your part of the business. You have the accountability of all validation aspects
and must ensure that systems are properly validated and works as intended.
- You will prepare and implement the validation documentation required to assure the proper development of a project and support regulatory submissions.
- You will act as a validation representative for projects and :
- Define and implement all validation activities related to the project.
- Develop the Validation Plans: define validation methodology and approach
- Provide validation expertise and guidance for the development of the project.
- Participate in the risk assessment related to the project.
- Review URS, FS and DS for validation requirements.
- Prepare and implement commissioning, IQ, OQ & PQ protocols.
- Manage traceability throughout the whole project validation file (from URS to PQ).
- Organize and coordinate commissioning, IQ, OQ & PQ validation activities with the different involved departments (on the ground, as required)
in such a way that all of them concur with the timeframes committed with the project leader.
- Participate to testing activities, analyze, interpret, document and report the testing results.
- Ensure the follow-up and tracking of the validation activities. Update the validation documentation system.
- Assure feedback of status and issues to Quality department head.
- In collaboration with QA representative, you will manage deviations and changes in order to guarantee that these are well documented
and that corrective actions are taken and followed-up upon.
- You will be involved in the development of expertises in IT technical solutions and also align validation aspects accordingly
- You will have to coordinate activities of validation engineers and contractors.
- You hold a Master in electronics, electromechanical or mechatronics
- You have at least 3 years of proven experience in Automation or a similar position in a manufacturing environment
- You have a good knowledge of :
- Manufacturing Systems (MES)
- Manufacturing process,
- Validation methodologies (GAMP5, ASTM 2500...)
- 21CFR part 11 and global European & FDA regulations as well as GMPs.
- You are fluent in French with a good level of English
- Corporate values mean a lot for us. We expect them to mean something for you
Nalys is a people company. We will give you the opportunity to challenge yourself while doing something you love.
So whether you are a creative, a dreamer or an achiever, you can find a way to do something you truly enjoy.
And because we want our company values to be more than words, we invest 7% of our annual revenue to drive innovation,
develop your expertise, train your brains and give you time & tools to think big.