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 / SOPs and Risk Assessments aligned with applicable regulatory expectations and industry standards.Developing 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 systems.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 field.A minimum of 5 years of experience in CSV, MES, SCADA, and OT systems.Good understanding of manufacturing processes and related process equipment.Extensive experience in a regulated pharmaceutical environment and GMP requirements.Ability to prioritize and manage work to critical project timelines in a fast-paced environment.Structured, focused, and well-organized working attitude.Independent way of working and taking ownership of assigned tasks.Working knowledge of quality systems and regulatory requirements across multiple health authorities.Proficient in Spanish and English.Ability to travel occasionally to different sites (Denmark and Switzerland).BeneficiosStart-up and innovative company within a fast decision environment.Flexible working hours (on site).International and highly motivated team.Attractive salary.Language courses offered.
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