Analyst I Quality Assurance
il y a 2 jours
Beckman Coulter Life Sciences’ mission is to empower those seeking answers to
life’s most important scientific and healthcare questions. With a legacy spanning 80+
years, we have long been a trusted partner to our customers, who are working to
transform science and healthcare with the next groundbreaking discovery. As part of
our team of more than 2,900 associates across 130 countries, you’ll help drive our vision
of accelerating answers—and our commitment to excellence.
Beckman Coulter Life Sciences is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.
Do you want to work in _Qualification/ Validation team?_ Do you enjoy leading _new challenge /project (milestone), Delivering Green Quality Metrics, Ensuring compliance with major regulatory, being in touch with the field _? Then read on
We are currently seeking a _Qualification Engineer (f/m)_ who will be responsible for_ Qualification/Validation activities for the whole site. _
In this role, you will be responsible for:
- _ Qualification of production and laboratory equipment_
- _ Write protocols and perform acceptance tests at the supplier and at the customer site (FAT/SAT)_
- _ Write and perform Installation, Operational and Performance Qualification (IQ, OQ, PQ) protocols, write the reports and manage associated non-conformities._
- _ The drafting of Validation Plan (VMP) up to Validation reports_
The required qualifications for the job include:
- _ Academic degree(s) with focus in qualification/ validation or any other related field._
- _ First experience in qualification/ validation in the pharmaceutical, biotech, chemical or similar industries_
- _ Fluency in English and French is required._
- _ You have good analytical and synthesis skills as well as diligence and team spirit._
**It would be a plus if you also possess previous experience in**:
- _ You also have skills in computerized systems, Quality Control department skills and Metrology._
- Remote or Hybrid language goes here (select one of these if remote or Hybrid): No possible to have a full time on site ? _
- Pay transparency language for locations where it may be required by law:_
The salary range OR the hourly range for this role is _._ This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range. This range may be modified in the future.
This job is also eligible for bonus/incentive pay.
We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.
La mission de Beckman Coulter Life Sciences est de donner à ceux qui cherchent des réponses à leurs questions les questions scientifiques et de santé les plus importantes de la vie. Avec un héritage s’étendant sur 80+ ans, nous sommes depuis longtemps un partenaire de confiance pour nos clients, qui s’efforcent de Transformez la science et les soins de santé grâce à la prochaine découverte révolutionnaire. Dans le cadre de l' Notre équipe de plus de 2 900 associés répartis dans 130 pays, vous contribuerez à concrétiser notre vision d’accélérer les réponses et notre engagement envers l’excellence.
Beckman Coulter Life Sciences est l’une des 10 sociétés de sciences de la vie de Danaher. Ensemble, nous accélérons la découverte, le développement et la mise en œuvre de solutions qui protègent et améliorent la santé humaine.
Vous souhaitez travailler au sein d’une équipe de qualification/validation ? Aimez-vous diriger de nouveaux défis/projets (jalons), fournir des mesures de qualité vertes, assurer la conformité aux principales réglementations, être en contact avec le terrain ? Alors lisez la suite
Nous sommes actuellement à la recherche d’un(e) Ingénieur(e) Qualification (f/h) qui sera responsable des activités de Qualification/Validation pour l’ensemble du site.
**Dans le cadre de vos fonctions, vous serez responsable de**:
- Qualification des équipements de production et de laboratoire
- Rédiger des protocoles et effectuer des tests d’acceptation chez le fournisseur et chez le client (FAT/SAT)
- Rédiger et exécuter les protocoles d’Installation, d’Exploitation et de Qualification des Performances (QI, QO, QP), rédiger les rapports et gérer les non-conformités associées.
- La rédaction de Plan de Validation (VMP) jusqu’aux rappo
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