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Bacthera AG
León, Castilla y León, Spain
Senior Qualification & Validation Expert Senior Qualification & Validation Expert (f/m/d) 100% 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 facil
Fuente del trabajo: Bacthera AGEbury
León, Castilla y León, Spain
Ebury is a hyper-growth FinTech firm, named in 2021 as one of the top FinTechs to work for by Glassdoor and AltFi. We offer a range of products including FX risk management, trade finance, currency accounts, international payments and API integration. Transaction Monitoring Senior Analyst Ebury León - 4 days in the office Department: Operations - S
Fuente del trabajo: EburySDi Digital Group
León, Castilla y León, Spain
Why SoftwareOne? The SoftwareOne Marketplace Platform Team is seeking a Senior DevOps Engineer who enjoys working with the latest technologies and practices and are inspired to learn new things in new ways. You will be helping us drive our infrastructure automation projects as part of an engineering team that prides itself on understanding the bu
Fuente del trabajo: SDi Digital GroupEbury
León, Castilla y León, Spain
FP&A Manager Ebury - León Office - 4 days per week office based working - 1 day per week working from home The FP&A (Financial Planning & Analysis) Manager plays a critical role in providing financial insights and analysis to support the strategic decision-making process across the organization. This individual will be responsible for conducting
Fuente del trabajo: EburyAccenture
Spain
Descripción Del Puesto#LI-EUEsta es tu oportunidad para unirte a un equipo diverso de personas apasionadas por el Big Data.En buenas manos ¡las tuyas! las enormes cantidades de información que las empresas recopilan hoy pueden convertirse en un activo muy valioso manejadas estratégicamente. Ayudamos a nuestros clientes a ser más eficientes haciendo
Fuente del trabajo: AccentureThermo Fisher Scientific
León, Castilla y León, Spain
Job Description Job Title: Automation Process Manager Requisition ID: When you join us at Thermo Fisher Scientific, you’ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of +$30 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to m
Fuente del trabajo: Thermo Fisher ScientificJJA.CO
León, Castilla y León, Spain
Great opportunity work on cutting edge technology that track and predicts wildfires to help government agencies, insurance companies and utilities companies. You will be working on technology that helps save lives and fight the effects of climate change. Company is founded by one of the World leading experts on wildfires. Team and this job are loca
Fuente del trabajo: JJA.COTelice
León, Castilla y León, Spain
Producto Flexibilidad Innovación IA En Telice diseñan, instalan y mantienen sistemas de electrificación, señalización y comunicación para el sector ferroviario e industrial. Su lema es "Tecnología sobre el terreno", lo que resume en una sola declaración su misión de proporcionar tecnología de vanguardia. Ahora, están buscando un perfil .NET q
Fuente del trabajo: TeliceLeón, Castilla y León, Spain
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
Tareas
Developing 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
Requisitos
Bachelor 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)
Beneficios
Start-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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Senior CSV Expert ofertas de trabajo en León, Castilla y León, Spain
ⓘ Se produjo un error inesperado al procesar tu solicitud.
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Si el problema persiste, contáctanos con tu problema.
Siempre puedes gestionar tus preferencias y actualizar tus intereses para asegurarte de recibir las oportunidades más relevantes.
Prepárate para descubrir tu próxima gran oportunidad.