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
TareasDeveloping CSV Policies / SOP`s and Risk Assessments aligned with applicable regulatory expectations and industry standards
Developing of protocols for CSV in accordance with policy and procedures
Leading assigned CSV for the process equipment of 4 facilities and providing guidance to local teams
Leads and supports CSV projects and related activities for IT supported system
Delivery of a complete validation package
User Requirements Specification (URS), Validation Plan (VP), Installation/Operational/Performance Qualification Protocol and Execution
Traceability Matrix, Validation Summary Report, Configurations Specification
Coordinating the cooperation between other system stakeholders (e.g. IT, Suppliers, etc.) including the alignment of Service Level needed
Coordinating/Handling the CSV tasks
Follow up changes and incidents for GMP/CSV relevant systems in collaboration with system Admin and IT
Performing the yearly system review for each system
Reviewing and analyzing related Deviations, CAPAs and Changes
Coordinating and communicating with stakeholders to ensure accurate and timely completion
RequisitosBachelor 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)BeneficiosStart-up and innotative company within a fast decission environment
Flexible working hours (on site)
International and highly motivated team
Atractive salary
Languages courses offered
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