Computerized System Validation Engineer CSV

 — Neuchatel
02.03. | Cadre di­ri­geant | 100%

Introduction :

Référence filiales : 201-NEUCHÂTEL

Nom du conseiller : Kovacevic Suzana

Nom de la filiale : 11

Adresse :

Rue du Sablon 2



Description de l'entreprise :

Do you want to join an International Company? Do you speak fluent English? Do you love challenges? Join us!

Secteur d'activité : Technical & Engineering

Computerized System Validation Engineer CSV


Provide support and expertise on qualification and validation of manufacturing equipment and Computerized Systems according to PMI procedures and policies as well as legal requirements (FDA)Coordinate and run CSV projects execution ensuring timelines are met in accordance with established plan Prepare, review and manage the workflow of all GxP system life cycle deliverables (URS, Design Specifications, Test Plan, FAT, SAT, IQ, OQ, PQ, Traceability Matrix and Test Summary Report)Plan, prepare and execute all activities of Commissioning, Qualification and Validation related to the Computerized Systems in close collaboration and interaction with external suppliers and PMI internal resources.Establish a good and efficient channel of communication with the different members of the project team IT, operation, Quality and technical servicesManage all changes through deviation, change control, NC and CAPAs following PMI QMS.

Date d'entrée : 02-03-2021

Type de société : Entreprise privée

Reference : 208047-11-3

Date de publication : 2021-03-02 16:09:54

Profil recherché :

Education: Master's degree or Bachelor in Computer Science, Life Sciences, Engineering, Biotechnology, Physics, Chemistry, Automation or equivalent Work experience: 3 years proven track record in Computerized System Validation in Pharmaceutical or Life Science environment.Other skills:Strong understanding of qualification and validation of manufacturing equipment and Computerized Systems.Strong understanding of control systems (PLC, SCADA, HMI)Strong understanding of IT systems (MES, Data Historian, Reporting Systems and IIoT systems)Strong understanding of IT environment (Server, network, database)Strong project management skills with the ability to prioritize assignmentsFamiliar with GxP systemsFluent knowledge of ASTM-E2500, GAMP 5, CFR 21 Part 11 and Data Integrity conceptLanguages: fluent in English and French Excellent analytical and problem-solving skills.

Pays : Suisse

Lieu de travail : Neuchâtel

Code postal : 2000

Catégorie : Contrôle Qualité / Process;Ingénieur / R & D

Niveau d'études : Expérience professionnelle : Début du contrat : 02.03.2021Durée du contrat : Not specified

Conclusion :

Don't hesitate to apply.