About the job Mission:
- You will be part of a worldwide project, supervised by a global team.
- 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) solution based on the Siemens XFP software across our client's facilities (Europe, US and Singapore).
- To help our client facing the increased number of projects and reinforce standards across facilities, our company 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 time frames 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
- Our company 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.