Technicien Qualification/VSI F/H

I apply
Published on 03/07/2026

  • Contract type:  Temporary contract - 6 months

  • Work time:  Full time

  • Location Javené

L'entreprise

Would you like to be part of an exciting journey that combines growth, innovation, and health?

In an environment that merges the strength of a cutting-edge industry with the agility of a start-up?


Join us!

 

A pioneer in the bacterial fermentation of hyaluronic acid, HTL Biotechnology is now the global leader in the development and sustainable production of innovative pharmaceutical-grade biopolymers.

Our mission is to unlock the potential of biopolymers to improve health, quality of life, and well-being for patients around the world.

By 2030, our biopolymers will benefit more than 500 million patients suffering from eye diseases, rheumatologic conditions, and skin aging.

 

HTL Biotechnology is an equal opportunity employer. In accordance with anti-discrimination law, we prohibit discrimination and harassment of any type and afford equal employment opportunities to employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.

 

To learn more about HTL Biotechnology: https://htlbiotech.com/

Description du poste

Au sein du service Qualification, Métrologie& VSI, le/la technicien(ne) participe à la qualification des équipements, installations et systèmes informatisés (QC, QI, QO, QP et VSI) garantissant la conformité du site aux exigences réglementaires (BPF, Annexe 15, GAMP 5, 21 CFR Part 11). Il/elle contribue également aux actions d'amélioration continue (Lean / QMVSI) du service.

 

Vos missions sont les suivantes : 

 

Qualification d'équipements, installations et utilités

·       Participer aux Analyses de risque équipements

·       Rédiger les protocoles de qualification (QC, QI, QO, QP) selon les référentiels en vigueur (BPF partie 2/Annexe 1/Annexe 15)

·       Réaliser les essais et documenter les résultats

·       Analyser les écarts et proposer/suivre les actions correctives (CAPA)

·       Rédiger les rapports de qualification

 

Validation des Systèmes Informatisés (VSI)

·       Participer aux analyses de risque

·       Rédiger et exécuter les protocoles de validation( QI/QO)

·       Vérifier la conformité 21 CFR Part 11

·       Assurer le suivi du cycle de vie des systèmes (changements, périodicité de revalidation)

 

Amélioration continue / QMVSI

·       Participer aux chantiers Lean (5S, résolution de problèmes, standardisation des pratiques)

·       Contribuer au suivi des indicateurs de performance (KPI) du service

·       Proposer des actions d'optimisation des processus de qualificatio

 

Profil recherché

De formation Bac +2/3 en métrologie, mesures physiques, instrumentation, qualité, ou équivalent, vous justifiez d'une première expérience en environnement BPF/VSI et Data intégrité. 

Team player, vous êtes rigoureux et exigeant, votre capacité à prendre des iniatives et à proposer des solutions vous permettront de mener à bien votre mission. 

 

Ce poste est à pourvoir dans le cadre d'un CDD de 6 mois.

Réf: aa84ff6f-84ae-4bd7-af97-c8beef6c355f

Apply

Technicien Qualification/VSI F/H

Temporary contract - 6 months
Full time
Javené

As part of your application on the career site of HTL Biotechnology, the information you provide is processed for the review of your profile, on the basis of pre-contractual measures and the legitimate interest of the company in building a CV database.

Some data may be automatically analysed (parsing and pre-screening) via an Artificial Intelligence system. No decision is made solely by AI, as every application is reviewed by a recruiter.

Regarding the use of AI:

- Your data is not retained by our AI solution.

- It is not used to train an AI model.

- Processing is carried out exclusively on servers located within the European Union.

- No transfer outside the EU is carried out.

Regarding your data:

Unless otherwise requested, your data is retained for a maximum of 2 years.

In accordance with our internal security policies (PSSI) and current best practices, robust technical and organisational measures are implemented to protect the access and integrity of your information: secure access, rights management, encryption, security protocols, access monitoring, employee awareness, etc.

Regarding your rights:

In accordance with the GDPR, you have the right to access, rectify, object to and delete your data. You may exercise these rights by contacting dpo@septeo.com.

* Required fields

Share job

Our last jobs

See more jobs