Computer System Validation
Vor 3 Tagen
Expleo propose une offre unique de services intégrés d'ingénierie, qualité et conseil stratégique pour la transformation digitale. Dans un contexte d'accélération technologique sans précédent, nous sommes le partenaire de confiance des entreprises qui innovent. Nous les aidons à développer un avantage compétitif et à améliorer le quotidien de millions de personnes.
Expleo Life Sciences Switzerland spécialisé dans les métiers de l'ingénierie en life sciences (industrie pharmaceutique, biotechnologie, chimie fine et dispositifs médicaux), renforce ses équipes en Suisse et recrute un(e) Ingénieur(e) Computer System Validation (CSV) Spécialiste avec expérience en Biotech.
Être consultant/e chez Expleo Life Sciences Switzerland, c’est :
- Accomplir des défis pour participer au développement de l’entreprise
- Intégrer une équipe dynamique
- Avoir un accompagnement humain à chaque mission et un suivi performant de votre carrière
- Réaliser des activités mensuelles afin d’établir de nouveaux contacts
- Participer au sein de l’entreprise à des événements spéciaux dédiés
- Pouvoir réaliser des formations pour développer ses capacités professionnelles
Contexte et responsabilités du poste
Intégré(e) au sein des équipes de notre client, vous participerez aux différentes phases des projets afin de concevoir ou améliorer les opérations actuelles, et de déterminer des processus plus efficaces.
- Création, rédaction, mise à jour des documents de qualification selon procédures en vigueur. Cela comprend : Les Plans de qualification / validation (VP) ; Protocoles / rapports de qualification (IQ, OQ, PQ) ; Matrices de traçabilité (TM)
- Organiser et mener l’exécution de tests de qualification IQ/OQ/PQ.
- Collaboration avec les services globaux et les autres sites participants aux qualifications initiales et les différentes modifications.
- Rédaction et suivi des déviations selon le système en place lors des qualifications initiales
- Assurer le maintien des indicateurs de performance du service
- Participation active à l’amélioration des processus de qualification en place
Expériences
Vous disposez d’un esprit d’analyse des opérations et d’une capacité à résoudre des problèmes. De solides compétences en direction et en participation aux discussions de projets sont essentiels.
Les requis pour accéder au poste sont les suivants :
- Au moins 3 ans d’expérience dans un environnement BIOTECH (environnement GMP)
- Expériences en qualification
- CSV/ Data integrity (21 CFR part 11)
- Systèmes Informatisés/ Automatisés (SI/SA) : Discoverant (Monitoring Process), Manufacturing Execution System (MES Batch record), Digital Plant Transformation (DPT)
- Aisance avec les outils bureautiques, notamment Word, Excel et PowerPoint
- Très bon niveau d’anglais/français (oral et écrit)
N'hésitez pas à postuler directement : constance.crinon@explegroup.com
Essential skills #J-18808-Ljbffr-
Computer System Validation
Vor 3 Tagen
Lausanne, Schweiz Expleo VollzeitOverviewExpleo Life Sciences Switzerland spécialisé dans les métiers de l'ingénierie en life sciences (industrie pharmaceutique, biotechnologie, chimie fine et dispositifs médicaux), renforce ses équipes en Suisse et recrute un(e) Ingénieur(e) Computer System Validation (CSV) Specialist.Être consultant/e chez Expleo Life Sciences Switzerland, c’est...
-
Linux System Administrator
vor 1 Woche
Lausanne, Schweiz MindMaze VollzeitCompany Description MindMaze is a global leader in digital neuro-therapeutics (DTx) solutions with a mission to accelerate the brain's ability to recover, learn and adapt. With over a decade of work at the intersection of neuroscience, bio-sensing, engineering, mixed reality, and artificial intelligence, our healthcare division is addressing some of the most...
-
Linux System Administrator
vor 1 Woche
Lausanne, Schweiz MindMaze VollzeitCompany Description MindMaze is a global leader in digital neuro-therapeutics (DTx) solutions with a mission to accelerate the brain's ability to recover, learn and adapt. With over a decade of work at the intersection of neuroscience, bio-sensing, engineering, mixed reality, and artificial intelligence, our healthcare division is addressing some of the most...
-
Linux System Administrator
Vor 7 Tagen
Lausanne, Schweiz MindMaze VollzeitCompany Description MindMaze is a global leader in digital neuro-therapeutics (DTx) solutions with a mission to accelerate the brain's ability to recover, learn and adapt. With over a decade of work at the intersection of neuroscience, bio-sensing, engineering, mixed reality, and artificial intelligence, our healthcare division is addressing some of the most...
-
Linux System Administrator
Vor 2 Tagen
Lausanne, Schweiz Anderson RH VollzeitMaster's degree in engineering, computer science, or equivalent work experience - +5 years experience in Linux system administration and networking - Linux shell scripting, programming skills (Bash, Python, Perl, Java...) and virtualisation experience - You will join a small team and participate in the maintenance and evolution of IT infrastructures. The HQ...
-
System and Network Administrator
vor 2 Wochen
Lausanne, Schweiz Frontiers VollzeitWe are on a mission to make science open so everyone can live healthy lives on a healthy planet Who we are Frontiers is the 3rd most-cited and 6th largest research publisher and we publish groundbreaking discoveries by the world's top experts. Scientists empower society and our mission is to accelerate scientific discovery by making science open. We place...
-
P2257 - Safety Systems Administrator
Vor 6 Tagen
Lausanne, Schweiz Debiopharm Vollzeit**_Debiopharm_**_ is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to develop...
-
Linux System Administrator
Vor 6 Tagen
Lausanne, Schweiz MindMaze VollzeitCompany Description Founded in 2012, MindMaze is a global leader in brain technology and digital neurotherapeutics solutions for brain health and recovery. Its mission is to accelerate the brain’s ability to recover, learn and adapt. The company has two core divisions - Healthcare and Labs - working collaboratively at the intersection of neuroscience,...
-
Quality Engineer
vor 1 Woche
Lausanne, Schweiz The Biopôle VollzeitResponsibilities:Serve as the quality reference for development and implementation of quality documentation related to the design technology and to the manufacturing process (i.e. Specifications, Validation Master Plan, Quality Plan, Process Validation Protocols and Reports).Interface with all partners involved in the development, manufacturing, and quality...
-
Channel System Engineer
vor 1 Woche
Lausanne, Schweiz Fortinet VollzeitChannel System Engineer Location: Lausanne area The Channel System Engineer plays a critical role in driving success with our channel partners, acting as a trusted technical advisor and solution architect. The role supports our channel sales efforts by engaging with partners and clients to demonstrate the technical value of our products, design custom...
-
Lead System Support Engineer
vor 1 Woche
Lausanne, Schweiz Genius Sports Group VollzeitSecond Spectrum is a Sports Emmy-winning data & tech company that is building the next way of seeing sports - by capturing and producing the highest quality data and innovative content for many of the world’s largest leagues and media partners, such as the NFL, NBA, English Premier League, ESPN, Amazon, and CBS Sports. We are pushing the boundaries of deep...
-
Lausanne, Schweiz NZZone VollzeitMaterials science and technology are our passion. With our cutting-edge research, Empa's around 1,100 employees make essential contributions to the well-being of society for a future worth living. Empa is a research institution of the ETH Domain.Focus on the design, control and integration of a novel reconfigurable manipulation system for aerial robotics...
-
Lead System Support Engineer
Vor 4 Tagen
Lausanne, Schweiz Genius Sports VollzeitThe Role : Lead System Support Engineer We are seeking a results-oriented, operationally-focused System Support Engineer Lead to provide front-line technical support and troubleshooting for our tracking and video augmentation products. You will lead a group of engineers supporting our camera, live data processing, and delivery systems and communicate...
-
System Support Engineer
Vor 4 Tagen
Lausanne, Schweiz Genius Sports VollzeitThe Role : System Support Engineer We are seeking a results-oriented, operationally-focused events engineer to provide front-line technical support and troubleshooting for our tracking and video augmentation products. You will communicate across teams and have the opportunity to work within multiple systems, analyzing, identifying and resolving issues...
-
Business Systems Analyst
Vor 4 Tagen
Lausanne, Schweiz Université de Lausanne VollzeitAramco Services Company Business Systems Analysts (844) Procurement & Supply Chain Mgmt - Houston, TX - Full Time Basic Function Provides technical expertise to department on business systems supporting departmental operations. Develops, or assists with the development of small and well-defined tasks of computer systems and programs...
-
C&q Lead
Vor 6 Tagen
Lausanne, Schweiz ALTOGEN AG Vollzeit**ALTOGEN** is a swiss engineering and consulting company specialized in life sciences with proven expertise in pharmaceuticals, biotechnology, medical devices. With several years of experience, technical expertise and project coordination, we support our partners throughout all areas of the product life cycles. We surround ourselves with junior to expert...
-
Business Systems Analyst
Vor 4 Tagen
Lausanne, Schweiz TN Switzerland VollzeitSocial network you want to login/join with:Business Systems Analyst (844), LausanneJob Reference:16675064fd6cJob Views:10Posted:21.01.2025Expiry Date:07.03.2025Job Description:Business Systems Analysts (844)Procurement & Supply Chain Mgmt - Houston, TX - Full TimeBasic FunctionProvides technical expertise to department on business systems supporting...
-
Cqv Lead Biotech/pharma
Vor 7 Tagen
Lausanne, Schweiz Capgemini Engineering VollzeitCritères de l'offre Description du poste - Lead and direct the Commissioning and Qualification team - Responsible for the compliance of all industrial assets, ensuring that the equipment meets regulatory requirements - Compliant implementation of new systems through the engineering project phase - Maintaining compliance of existing systems by delivering...
-
Lead System Support Engineer
Vor 4 Tagen
Lausanne, Schweiz TN Switzerland VollzeitWe are seeking a results-oriented, operationally-focused System Support Engineer Lead to provide front-line technical support and troubleshooting for our tracking and video augmentation products. You will lead a group of engineers supporting our camera, live data processing, and delivery systems. You will also have the opportunity to work within multiple...
-
Automation Engineer
vor 1 Woche
Lausanne, Schweiz Cognizant VollzeitAutomation Engineer - HVACReporting to: Automation Technical LeadJob Summary:We are seeking an Automation Engineer responsible for the design, configuration, commissioning, qualification, and reliable operation of the HVAC control systems at the Dolphin/ ADC project.Main Responsibilities:Provide design support for the DeltaV system configuration for utility...