Senior Validation Specialist

Boehringer Ingelheim

Ver: 45

Día de actualización: 19-09-2022

Ubicación: Sant Cugat del Vallès Cataluña

Categoría: IT - Software

Industria: Pharmaceutical Manufacturing

Tipo de empleo: Full-time

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Contenido de trabajo

At Boehringer Ingelheim we develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company, we focus on long-term performance. We believe that, if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve; after all, we started with just 28 people. Now, we are powered by 50,000 employees globally who nurture a diverse, collaborative and inclusive culture.

Our innovation power wouldn’t be possible without our people. That’s why in Boehringer Ingelheim you will have the opportunity to develop your career while improving the world’s health!

If you want to take one step forward in your professional journey in a virtual, international and multicultural environment, Boehringer Ingelheim is the one for you!

Growth together with the team as a and be part of a Global Top Employer company where you will be involved in interesting projects that which will lead you to your fullest development!

The Position

Be part of our team within IT RDM as IT Senior Validation Specialist! It is essential to guarantee the compliance of the entire application landscape with internal, external and regulatory requirements - but even more important - to make computer system validation SMARTER as we are doing it traditionally today and to enable a faster delivery of IT solutions to our business.

Duties & Responsibilities

  • Accountable for the availability and currency system life cycle documentation supporting data transformation, analysis and visualization withinMedicine/Clinical
  • Develop and maintain a risk based global validation concept that ensures an effective, efficient and compliant validation approach, based on the needs of the business processes and in alignment with the internal CSV&C and quality function
  • Coordinate and manage all internal and external resources involved in the process of computer system validation and ensure high quality standards of the delivered validation materials
  • Plan and coordinate validation deliverables within IT projects and manage interdependencies with other sub-projects to ensure in-time delivery
  • Present and defend the validation concept to compliance functions and authorities as part of regular reviews or audits/inspections
  • Shape and standardize efficient and innovative Computer System Validation (CSV) Standards for computerized systems across IT Medicine in accordance with pharmaceutical and BI Corporate requirements and drive to make this fit for future needs

Requirements

  • Bachelor or master’s degree (MBA, MSC) with major focus on IT, engineering, sciences, pharmaceuticals or biotechnology or equivalent and longstanding professional experience in regulations and processes.
  • Proven experience bringing mid-large scale projects to implementation using computer validation regulations and methods (e.g. , BI SOPs and Corporate Procedures, Good Clinical Practice (GCP), FDA Guidelines, Code of Federal Regulations (CFR), particularly 21 CFR Part 11) and data integrity.
  • Proficient knowledge and use of process analysis and user requirement engineering methods.
  • Work and project management experience in a complex virtual and global environment.
  • Experience in agile environments and project contribution in SCRUM and agile teams is a plus.
  • Cross-cultural competencies paired with fluent language skills in English is a must
  • Good technical understanding of respective regulations for computer system validation
  • Aligning test automation strategies, agree and keep oversight on quality gates together with project teams.
  • Very strong customer, service and quality orientation as well as teamwork and facilitation skills

#IamBoehringerIngelheimbecause…

With us, you can grow, collaborate, innovate and improve lives. We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices. In addition, flexible learning and continuous development for all employees is key, because your growth is our growth.

We are continuously working to create a great employee experience. These are some examples of how we will take care of you:

  • Flexible working conditions
  • Life and accident insurance
  • Health insurance at a competitive price
  • Investment in your learning and development
  • Gym membership discounts

If you have read until here, what are you waiting to apply? We want to know more about you!

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