What has a baby in Peru in common with one in Belgium or one in Vietnam?
Us, ZenTech! Because with our work we ensure that all these babies have a safer life start!
And we are the team of,
a biotechnology company specialized in the development of solutions including instruments, reagent kits and services for newborn screening laboratories.
Our solutions detect the presence of serious and treatable congenital disorders and metabolic errors in newborns before symptoms appear and harm is done to them.
Hence, our newborn screening devices are the first essential step before an eventual adapted treatment to ensure all newborns a safer life start.
If you want, you can join us to reach our objectives as a:
Your mission as Validation Officer:
With the implementation of the new European regulation on in vitro diagnostic devices (EU 2017/746) from May 2022 we have to meet new requirements in our industry, in particular regarding the Technical Documentation.
As Validation Officer your mission is to help achieving compliance of Technical Documentation requirements for our new and existing products.
Your main tasks as Validation Officer:
- Plan and conduct the experiments necessary to establish the analytical performance of ZenTech products based on ELISA or enzymatic test techniques, in accordance with applicable regulations (directive, standards, CLSI guidelines, regulations, etc.)
- Ensure the reliability and reproducibility of attained results
- Process the results obtained during product validation and analyze data in order to write the associated technical documentation
- Participate and present the progress of work during interdepartmental meetings
- Perform maintenance operations on the instruments in the R&D department
Your secondary tasks as Validation Officer:
Provide assistance with specific requests (especially from the Sales & Marketing department), by performing tests, processing data and reporting results.
Your expertise and skills:
- Experienced Bachelor or Master’s degree in sciences (Chemistry, Biochemistry or Biology)
- Experience in the IVD diagnostics industry is an asset
- Statistics applied to bio-assays
- English: oral and reading comprehension, strong writing skills
- Autonomous worker yet team player
- Rigorous and organized
- Strong Quality Assurance / Regulatory Affairs orientation
What we offer you:
- Permanent position
- A full-time position (38 h/w)
- A salary package based on your skills and experience
- Integration in a young and dynamic R&D-Validation team (5 people)
More information about us at ZenTech s.a. you find on our website www.zentech.be and if you are now interested to join us send us your resume and cover letter to:
Subject: Validation Officer
To the attention of Delphine DEBOIS