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.Bacthera is a leading contract development and manufacturing partner (CDMO) for biotech and pharma customers. We enable our customers to bring life-changing treatments to patients. We operate from our headquarters in Basel (CH) and have production facilities in Spain, Denmark and Switzerland. We bring together best-in-class, complementary capabilities and we are the first CDMO globally to provide a full supply chain that offers manufacturing of live bacteria strains for therapeutic use.CREATE YOUR OWN FUTURE ASSenior CSV Expert (f/m/d)As a successful CSV Engineer you ensure that Computer System Validations are performed according to global and local company policies and standards as well as legal requirements and requirements set by health authorities. You are responsible for planning, developing and executing Computer System Validations for 4 Facilities. You will report to the global Head of Engineering Quality.My main tasks will be...Developing CSV Policies / SOP`s and Risk Assessments aligned with applicable regulatory expectations and industry standardsDeveloping of protocols for CSV in accordance with policy and proceduresLeading assigned CSV for the process equipment of 4 facilities and providing guidance to local teamsLeads and supports CSV projects and related activities for IT supported systemDelivery of a complete validation packageUser Requirements Specification (URS), Validation Plan (VP), Installation/Operational/Performance Qualification Protocol and ExecutionTraceability Matrix, Validation Summary Report, Configurations SpecificationCoordinating the cooperation between other system stakeholders (e.G. IT, Suppliers, etc.) including the alignment of Service Level neededCoordinating/Handling the CSV tasksFollow up changes and incidents for GMP/CSV relevant systems in collaboration with system Admin and ITPerforming the yearly system review for each systemReviewing and analyzing related Deviations, CAPAs and ChangesCoordinating and communicating with stakeholders to ensure accurate and timely completionI bring with me...Bachelor or Master's degree in Engineering, IT, Pharmaceutical Technology, Biotechnology or related fieldA minimum of 5 years of experience in CSV, MES, SCADA and OT systemsGood understanding of manufacturing processes and related process equipmentExtensive experience in a regulated pharmaceutical environment and GMP requirementsAbility to prioritize and manage work to critical project timelines in a fast-paced environmentStructured, focused and well-organized working attitudeIndependent way of working and taking ownership of assigned tasksWorking knowledge of quality systems and regulatory requirements across multiple health authoritiesProficient in Spanish and EnglishAbility to travel occasionally to different sites (Denmark and Switzerland)My reasons for choosing Bacthera..
