7 offres à pourvoir

Pilotage d’études techniques : Analyse des différents points ouverts générés par les services ou remontés par le client final. Recherche de solution (pour la série et le retrofit le cas échéant) et résolution de problèmes. Conception ou re-conception d’ensembles mécaniques ou pièces jusqu'à l'officialisation des données dans le système PDM. Développement de prototypes. Instruction de dossier de modifications (présentation ppt, redline, rapports d’essais…). Vérification de plans. Interlocuteur technique privilégié pour l’intégration mécanique auprès du client final : Préparation et animation des réunions techniques mensuelles avec le client final, en étroite collaboration avec l’Ingénieur en Chef du projet. Présentation et argumentation des modifications techniques. Interface technique pour le département Achats : Réponses aux questions techniques provenant des acheteurs. Soutien technique lors de l’élaboration de dossier de réclamation fournisseur. Pilotage et suivi de...

Within electronics and manufacturing department, the CSV Specialist plans, writes implements and reviews the Computer Systems Validation protocols in place within highly regulated manufacturing industries. The role of the CSV consultant is essential to make sure that all computer-based systems are operating as intended and meet regulatory requirements. Writing, review, and approval of validation SOPs and documentation Maintain accurate validation documentation Train other staff members on the correct use of computerized systems in line with protocols and regulations Keep up to date with advances in the field and, in particular, the regulatory requirements Involvement in review and updating of validation documentation Review and analyze validation data – compiling reports when required Recommendation of process upgrades and improvements in efficiency Implementation of such improvements Involvement in both internal audits and external inspections as required Minimum 5 years of...

Accompagner des équipes clientes dans la phase de conception, Développer de nouvelles applications et/ou des évolutions, Participer aux différentes phases de tests, Etre force de proposition et faire part de son retour d’expérience auprès des équipes métiers et techniques, Environnements projets : Agile / Scrum / SAFe. Expérience minimum de 2-3 ans en tant que développeur Full Stack : Concevoir le code back-end et les API d'accès aux données sous forme de webservices, en utilisant Java (version 8 et plus), Concevoir le code front-end en JavaScript et ses bibliothèques, HTML ou CSS, Utiliser des frameworks de développement tels qu’Angular, JQuery, Spring (boot, batch, core), Struts, Hibernate, Bootstrap, Utiliser des outils de support au développement tels que Git, Jenkins, Jira, Maven, etc., Participer à la définition de feuilles de route techniques et fonctionnelles, Mettre en place des infrastructures efficaces et évolutives prenant en charge le développement d’applications....

The main focus of the C#/.Net Developer will be new features development for the client’s plateform. This includes specifications, development, tests activities and documentation reviews. Software Engineering, Computer Science Engineering or Telecommunication Engineering degree. Required software development best practices (C++ and C#/ Net, Visual Studio, Angular). Participation in the testing activities: unit tests, integration tests, test automation with Selenium. Rigorous mindset, attention to details. Fluent in English; French and Italian an asset. Good understanding and proven experience working under software project methodologies (Waterfall, Agile). Experience in regulated environment or Hospital IT is a plus. Strong interpersonal skills, excellent oral and written communication. Team player on internal/external, national/international teams. Autonomous, must be able to work with minimal supervision.

Define the technology transfer strategy Support the technology transfers and process validation  to the new biotech production site Support the implementations and performance of Quality operations (new process introduction, electronic batch records, change controls, quality events, periodic reviews, change-over management and others) Act within compliance and legal requirements as well as within company guidelines Work with the project team and the engineering companies on the detailed design deliverables concerning process equipment requirements and actively support the risk assessment exercises (FMECA) Review and approve process equipment related documentation (procedures, layouts, FAT/SAT protocols and reports, qualification protocols and reports, CAPAs, deviations and change controls) to ensure compliance with cGMP and applicable regulations Support the Commissioning & Qualification activities during FAT at supplier’s and on site in close collaboration with manufacturing...

As a consultant, you will support the qualification and validation commissioning and qualification of labs equipments Key responsibilities : Act as the main point of contact for all quality compliance key topics regarding labs equipments Review and approve the URS and relevant documentation and support actively the risk assessment exercises (FMECA) Support the Commissioning & Qualification activities Support the creation of procedures, protocols and reports for qualification / validation Ensure qualification and validation of labs equipments Act within compliance and legal requirements as well as within company guidelines Foster the understanding and the application of Good Manufacturing Practices (cGMPs) by bioplant employees Implementation and ensures adherence of appropriate regulations and quality standards, Write, review and approve Standard Operating Procedures (SOPs), Quality Risk Assessments (QRAs), specifications, Batch Production Documents (BPDs) or Manufacturing...

Responsible for ensuring effective sterility assurance and environmental monitoring programmes are deployed in compliance with current GMP,and Client strategy. Supports development and implementation of microbiology/sterilization practices for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.Supports development and implementation of microbiology/sterilization practices for the effective and efficient development, transfer, and maintenance of processes. Participate in complaints investigation, Nonconformance and quality incidents investigation, act as technical approver. Provide technical support in interpretation of Microbial Identification and Environmental Monitoring data and for the trending of EM and Microbiological data including setting of appropriate Alert limits Responsible for the Tracking and Reporting or Quality Metrics for internal and external use. Qualification, Auditing and monitoring the...