Validation Expert for Computerized Systems

hace 5 días

Barcelona, Barcelona, España Fresenius Kabi A tiempo completo

About The Role
The Team Computer Software Assurance ensures that applications developed in Digital Operations – Manufacturing IT are validated according the significant regulations and guidelines. Therefore the team operates a validation support tool (Polarion by Siemens) to support the development team in the validation process. In addition, the team fosters to follow the Fresenius Kabi QA principles in development activities.

Your Key Responsibilities

  • Support and validation guidance in validation projects of computerized systems according Computer Software Assurance (CSA) method as validation team lead (Validation Manager).
  • Support of the development teams in using a digital validation support tool (Polarion from Siemens) in validation projects.
  • Support and preparation of respective procedures and / or work instructions to support qualification and validation of computerized systems.
  • Auditing of software vendors and suppliers.
  • Review and auditing of GMP-compliant qualification and validation of corporate computerized systems as relevant and used in Digital Operations department.
  • Training of development teams in CSA and general validation principles within Digital Operations department.
  • Continuous improvement of CSA validation process as implemented in Digital Operations department.
  • Assure that computer software validations are done compliant and in consistency with relevant regulations and guidelines.
  • Assure that QM principles are followed in validation projects.
  • Escalation if CSA principles are disobeyed.
  • Re-qualify / re-audit software vendors and supplier to maintain their qualified status.

Your Skills And Experiences

  • Academic degree (Master or comparable degree).
  • Profound experience in computerized system validation / computer software assurance.
  • Good knowledge of EU GMP Annex 11, US FDA 21 part 11 and GAMP 5.
  • Knowledge and understanding of corporate SOPs and Wis related to computer software validation and Quality and Risk Management.
  • Good software knowledge (Service Now / Polarion / Office) and basic knowledge of QM principles.
  • Proactive working and prioritizing tasks according to the requirements of the validation project.
  • Critical, creative and problem-oriented thinking in validation projects.
  • Team player with appropriate soft skills as well as good leadership skills, high motivation, good in decision-making and reliable.
  • Experience and readiness to work in multi-cultural and changing teams.
  • Good presentation and problem-solving skills.
  • Excellent English language skills.
  • Global travelling readiness.

Why join us?

At Fresenius Kabi, you'll contribute to something meaningful: delivering life-saving therapies to patients around the world. As part of a global transformation, you will work in a highly visible, impactful role with the opportunity to shape how we manage software development and delivery. You will join a diverse and dynamic team in a collaborative environment where your expertise will help drive innovation, efficiency, and quality across our digital landscape.

  • Validation Expert for Computerized Systems

    hace 2 semanas

    Barcelona, Barcelona, España Fresenius Group A tiempo completo

    About the role:The Team Computer Software Assurance ensures that applications developed in Digital Operations – Manufacturing IT are validated according the significant regulations and guidelines. Therefore the team operates a validation support tool (Polarion by Siemens) to support the development team in the validation process. In addition, the team...

  • Engineering intern- Systems Validation

    hace 5 días

    Barcelona, Barcelona, España GE Vernova A tiempo completo

    Job Description SummaryTest and Validation has the hardware (camera, tripods, auxiliaries) to apply the Motion Amplification technology, which is a new technology for vibration measurement in rotational machines, such as a Wind Turbine drive train. The purpose of this request is to understand how the hardware works and, together with design engineers,...

  • Engineering intern- Systems Validation

    hace 5 días

    Barcelona, Barcelona, España GE Vernova A tiempo completo

    Job Description SummaryTest and Validation has the hardware (camera, tripods, auxiliaries) to apply the Motion Amplification technology, which is a new technology for vibration measurement in rotational machines, such as a Wind Turbine drive train. The purpose of this request is to understand how the hardware works and, together with design engineers,...

  • Computer System Validation Senior Consultant

    hace 5 días

    Barcelona, Barcelona, España Rephine A tiempo completo

    Join Rephine Barcelona: Leading Life Sciences Quality WorldwideAt Rephine, we set the standard for quality assurance and GxP compliance in the Life Sciences industry. With offices in Barcelona, the UK, and China, we support the Pharmaceutical, Biotech, and Medical Device supply chains globally.Who We're Looking For:Are you passionate about consulting in the...

  • Engineering intern- Systems Validation

    hace 5 días

    Barcelona, Barcelona, España GE Vernova A tiempo completo

    Job Description SummaryAssessment of the uncertainties of the measurements in the validation of a Wind Turbine design across the full Data Acquisition chain. In a second step, extend the assessment to the uncertainties related to simulation and test prediction in the design phase.Job DescriptionEvaluation of measurements uncertainties in WT validationOne...

  • Engineering intern- Systems Validation

    hace 5 días

    Barcelona, Barcelona, España GE Vernova A tiempo completo

    Job Description SummaryAssessment of the uncertainties of the measurements in the validation of a Wind Turbine design across the full Data Acquisition chain. In a second step, extend the assessment to the uncertainties related to simulation and test prediction in the design phase.Job DescriptionEvaluation of measurements uncertainties in WT validation One...

  • Qualification & Validation Specialist

    hace 2 semanas

    Barcelona, Barcelona, España QbD Group A tiempo completo

    QbD Group team offers knowledge & tailored (software) solutions in development, clinical, regulatory & compliance, production and distribution for companies active in Pharma, ATMP and Medical Devices/IVD. We are always looking for the next QbD'er inProcess validation.What do we expect from you as a Qualification and Validation Specialist?As a Qualification &...

  • Senior Expert IT – EHS Systems

    hace 2 semanas

    Barcelona, Barcelona, España LSI Corporation A tiempo completo

    Arxada is a global leader in innovative solutions that protect our world. Our groundbreaking technologies, in-depth regulatory know-how, manufacturing and process development help our customers to safeguard nutrition, health and infrastructure efficiently through chemistry and biotechnology that enhance sustainability. We offer a broad portfolio of...

  • Senior Expert IT – EHS Systems

    hace 2 semanas

    Barcelona, Barcelona, España Arxada A tiempo completo

    Arxada is a global leader in innovative solutions that protect our world. Our groundbreaking technologies, in-depth regulatory know-how, manufacturing and process development help our customers to safeguard nutrition, health and infrastructure efficiently through chemistry and biotechnology that enhance sustainability. We offer a broad portfolio of...

  • Senior Avionics Validation

    hace 2 semanas

    Barcelona, Barcelona, España Minsait A tiempo completo

    Ubicación:B, ROPerfil profesional: Desarrollo de SolucionesExperiencia requerida: Más de 2 años de experienciaModalidad del puesto: HíbridoAbout Indra GroupIndra Group is a global leader in technology and consulting, driving innovation across defense, aerospace, air traffic, and digital transformation. Through our business units—Indra, a key player in...