Nos aseguraremos de que las personas con discapacidades reciban adaptaciones razonables para participar en el proceso de solicitud de empleo o entrevista de trabajo, para que puedan ejercer las funciones de trabajo esenciales y recibir otros beneficios y privilegios del empleo. Comuníquese con nosotros para solicitar una adaptación.
Engineer II, Validation
Share job link
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
The Tilburg site develops and manufactures gelatin-based drug delivery dosage forms. It has been a Thermo Fisher Center of Excellence since 1994, with extensive capabilities for various soft gel technologies. The site supplies medicine for important diseases and supports the innovation of new consumer products.
We need an experienced Computerized System Validation Engineer (CSV) to help with our digitalization and automation efforts. The CSV engineer will play a crucial role in the site transition and work closely with our IT organization.
Job description:
The role is within the validation team. The CSV engineer will work closely with manufacturing, IT, supply chain, and quality departments.
The responsibilities include leading GxP CSV projects to ensure compliance with cGMP, 21 CFR Part 11, GAMP5, and Annex 15. The CSV engineer is responsible for validating GxP systems, aligning with requirements, industry practices, and company policies. Projects may involve manufacturing, laboratory, and facility systems in a regulated environment. Familiarity with validation of cGMP automation/computerized systems is required, along with knowledge of industry standards and practices for computer validation. Relevant experience in validating Manufacturing and Laboratory systems in the pharmaceutical industry is essential for this role.
Hands-on experience in drafting documentation specific for computerized system validation, performing validation activities, and reporting the results are the main requirements for this role.
The computerized systems validation engineer should have a background in project management to help automate and digitize our processes and systems. They should be able to manage multiple projects and have strong communication skills.
Given the multitude of projects running within the validation department, sound decision-making in time-sensitive and sophisticated situations with a good assessment of risk are encouraged skills.
Qualifications:
Proven hands on experience in Commissioning and Validation gained preferably within a Pharmaceutical environment or equivalent that is a highly regulated environment
Ability to review and extract information from systems and put together reports for Periodic Review
Strong communication skills
Personal:
Diversity in our organization is an important element to build an effective and challenging working environment. Integrity, Intensity, Innovation, and Involvement are basic characteristics that we expect of all members of our organization.
A person who enjoys leading change and working within the matrix organization to improve internal processes, with a “can do” mentality, will discover happiness in this role.
Recibe notificaciones de trabajos similares
¡Error!
Recomendaciones de perfil
Trabajos similares
-
Engineer II, Operations Engineering
Ubicación Eindhoven, Países Bajos Id. del empleo R-01306862
In this function within Operations Engineering, you will support the sustainability of one of the advanced modules to the manufacturing, the FEG electron source. A bachelor or masters in a technical f...
-
Operations Engineer II
Ubicación Eindhoven, Países Bajos Id. del empleo R-01277852
In this function within Operations Engineering, you will support the sustainability of one of the advanced modules to the manufacturing, the FEG electron source. A bachelor or masters in a technical f...
-
Distribution Engineering Analyst
Ubicación Loughborough, Reino Unido Id. del empleo R-01294444
Use ERP/WMS system to analyse and supervise inventory storage and set-up across the DC network to ensure efficiency and productivity of the supply chain operations. Ensure ERP/WMS IT projects are deli...
-
Supervisor, Manufacturing Engineering
Ubicación Eindhoven, Países Bajos Id. del empleo R-01297219
Your team will work closely together with the PLM, Product Marketing, R&D, manufacturing, logistics, purchasing, quality, and Technical Service Support (TSS) groups within Thermo Fisher to ensure deve...
-
Technical Validation Engineer
Ubicación Eindhoven, Países Bajos Id. del empleo R-01304325
Coordinate, prioritize, and execute Engineering Change Orders (ECOs) and Engineering Change Requests (ECRs) during Product Lifecycle Management. Create implementation plans for assigned ECOs, act as t...
-
Validation Engineer
Ubicación Newport, Reino Unido Id. del empleo R-01305194
Develops and implements continuous improvement activities to enhance the quality system, such as Six Sigma, 5S, Lean Manufacturing methods, etc. Develops and implements technical quality training to b...
-
Process SME, Manufacturing Engineering
Ubicación Lengnau, Suiza Id. del empleo R-01305146
The Manufacturing Engineer 3 defines and implements process improvements, provides technical support to manufacturing operations, and improves manufacturing efficiency, reduces costs, and improves pro...
-
Manufacturing Engineer (II)
Ubicación Groningen, Países Bajos Id. del empleo R-01304312
Responsible in supporting the Drug Substance Manufacturing with preparing production documentation, planning, deviation investigation management, continuous improvement projects, supports training and...
-
Engineer II, Manufacturing Engineering
Ubicación Dartford, Reino Unido Id. del empleo R-01306328
Maintain and repair production and site services equipment to drive efficiencies through continuous improvement and TPM/Lean tools. Use TPM/Lean tools to successfully implement continuous improveme...
Los solicitantes de empleo también vieron
Nos aseguraremos de que las personas con discapacidades reciban adaptaciones razonables para participar en el proceso de solicitud de empleo o entrevista de trabajo, para que puedan ejercer las funciones de trabajo esenciales y recibir otros beneficios y privilegios del empleo. Comuníquese con nosotros para solicitar una adaptación.