Job Description Yacht Life Sciences has a vacancy for a Laboratory Automation Specialist at Janssen Biologics / Johnson & Johnson in Leiden, the Netherlands. Janssen Biologics B.V. is a multinational pharmaceutical company that has been for more than 25 years a leader in the field of biomedicines. We are looking for an Automation Specialist who has demonstrable laboratory experience and affinity with analysis methodology in combination with computerized systems. Data integrity, setting up and maintaining computerized systems as well as robotics are examples of Automation activities in support of well-functioning laboratories. You will act as a Subject Mater Expert regarding Automation topics, such as, data integrity, introduction and maintenance of analytical instruments. You will also contribute to maintaining cGMP compliance and support the LEAN status of the team. Tasks and responsibilities Responsible for the technical implementation of new systems within the organization in collaboration with other teams. Lab systems vary from (standalone) analytical equipment to complex global platform projects which connect to LIMS (Laboratory Information Management Systems). Implementation of SDMS (Scientific Data Management System) and future new paperless opportunities. Responsible for documenting administrator procedures, technical installation procedures and maintenance procedures. Responsible for data integrity, including backup and (disaster) recovery Provides support in case of (computerized) problems. Implementation of equipment from a 21CFR Part 11 compliance perspective Takes part in Lab Systems initiatives and projects, in cooperation with the global organization and in alignment with business needs. Responsible for software validation and delivery of validated methods to the lab to introduce new testing methods for new products within the QC Laboratories.
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