Cloud Engineer-Senior Consultant-Digital Excellence
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of Science At Dotmatics Our global team of more than 800 colleagues are dedicated to supporting our customers in over 180 countries. Together, with our scientific community of users, we accelerate scientific innovation in order to make the world a healthier, cleaner, and safer place to live.We are Science Driven. We are Customer Centric. We are Better Together What do we need As a Validation Engineer you will be responsible for developing and executing validation artifacts for Dotmatics Luma platform and its internal systems operating ensuring that our software systems meet GxP requirements through comprehensive validation activities, working closely with Quality Management, Engineering, and Product teams to maintain compliance with FDA regulations and industry standards.In this role you will get to:Develop and execute validation protocols (IQ/OQ/PQ) for software systems and tools used in GxP environmentsAuthor and maintain validation documentation including validation master plans, A leading technology firm in the UK is seeking a Validation Engineer to develop and execute validation protocols for their software systems. The successful candidate will ensure compliance with GxP requirements by developing validation documentation and supporting audits...., We're seeking a UI/UX-focused Senior Eclipse RCP / SWT Engineer to design and build high-performance Java thick-client applications using Eclipse RCP, OSGi, SWT, and JFace. You will partner with product, UX, and domain experts to deliver intuitive, robust, and responsive..., Senior Firmware EngineerLocation: Bristol; HybridJoin us at Smartbox as a Senior Firmware Engineer!Are you a passionate Firmware Engineer wanting to make a real impact by giving a voice to those without speech Smartbox is looking for a dedicated individual to help improve..., A leading digital science platform company in the UK is seeking a Validation Lead to oversee validation activities for the Luma platform. This role requires deep expertise in GxP compliance and experience with automated testing tools like Cypress. You will collaborate...
Requirements
protocols, reports, and standard operating proceduresFollow comprehensive validation plans following GAMP 5 principles, including risk-based approaches to validation activitiesEnsure all validation activities comply with 21 CFR Part 11, GAMP 5, ISO 9001 and applicable FDA guidanceMaintain validation documentation in accordance with quality management system requirementsSupport audit and inspection readiness through comprehensive validation recordsPartner with Software Engineering, Product Management and Quality Management on developing and reviewing validation artifactsSupport Change Control activities and assess validation impact of system changesWe are looking for people who canensure ongoing compliance through periodic system reviews, support revalidation and regression testing for system changes, participate in CAPA investigations, and drive continuous improvement of validation processes and efficiency.The key skills we are looking for:Experience in software validation, computer system validation (CSV), or related quality/compliance role within a regulated life sciences environment (pharma, biotech, or medical device)Strong understanding ofGAMP 5principles and risk-based validation approachesWorking knowledge of 21 CFRPart 11requirements for electronic records and signaturesFamiliarity withISO 9001quality management system principlesYou may also have:Bachelor's degree in Computer Science, Biology, Chemistry, Engineering, or related technical field, preferred but not requiredQMS and regulatory compliance experienceUnderstanding of software development lifecycle (SDLC) and Agile methodologiesExperience with validation of cloud-based systems, SaaS applications, or commercial off-the-shelf (COTS) software#J-18808-Ljbffr Similar jobs
Benefits & conditions
About The RoleBespak are looking for a Principal Validation Specialist - CSV. This is a permanent position for the Holmes Chapel site, CW4 8BE. The salary for this role is £47,000 - £55,400. Other benefits you will receive are 25 days annual leave plus bank holidays,...