Job speichern Zurück zu Suche Stellenbeschreibung Übersicht Ähnliche Jobs hinzugefügt 10/06/2024Are you looking for your first experience in the Life Sciences industry?Are you interested in the medical device and pharmaceutical industries?FirmenprofilSwiss company involved in the development of advanced medical products.StellenbeschreibungTransfer of the design of new productsWork closely with the various departments and contract manufacturing organization to ensure the transfer of design into production of new products.Major stakeholder in the implementation of documentation to ensure the transfer stages from design to production of new products.Participate in the training of production teams to ensure the transfer of design into production of new products.Qualification and validation of equipment and processes.Define and implement process validation plans in accordance withCoordinate, supervise and/or plan process validation, equipment qualification, sterilization, cleaning validation and computerized systems activities in accordance withControl the implementation of all qualification and validation activities to guarantee the maintenance of validated statuses (equipment, processes, etc.).Contribute to the validation protocols andParticipate to the continuous assessment and optimization of manufacturing processes to improve efficiency, reduce costs, and enhance product quality.Participate in the identification and assessment of risks associated with manufacturing processes and take part in the development of strategies to mitigate these risks to ensure product consistent with defined final specifications.Represent the validation department during inspections and/or audits by regulatory agencies when required and provide necessary documentation.Technology operationsTechnology Transfer: together with the MS&T Manager, collaborate with R&D and QA/RA to facilitate the successful transfer of new products and technologies from the R&D phase to manufacturing. This includes providing expertise on scalability, process capability, and troubleshooting potential issues during the transfer.Major stakeholder in the resolution of non conformity related to products.Take part in supplier audits.Validation expert as single point of contact with the contract manufacturing organization.AnforderungsprofilEDUCATION/LANGUAGESDegree in the field of medical technology, engineering or related fieldFluency in English.PROFESSIONAL SKILLS & EXPERIENCEFirst experience in industrialization and validation within Medical device industryGood understanding of the different value streamsGood understanding of highly regulated environmentsStrong knowledge of ISO 17665-1 for the final sterilization of the product as well as ISO 13485 (quality management system for Medical Device) and ISO 14971 (risk management for Medical Device)Excellent computer skillsPERSONAL SKILLS & COMPETENCIESStrong ethics, creativity and problem solving abilitiesProactive and ability to initiate and self-start projectsPositive, flexible and resilient. Ability to handle ambiguity & changesExcellent planning, communication and presentation skillsStrong team player and ability to work across functionsSonstige InformationenLong-term project with possibility of internalisationKontaktPierre-Alexandre GoninReferenznummer angebenJN-062024-6448319ZusammenfassungBerufsfeldHealthcare & Life SciencesNäheres BerufsfeldMedical devicesBrancheHealthcare / PharmaceuticalOrtGenfVertragsartInterimBeraternamePierre-Alexandre GoninReferenznummerJN-062024-6448319