CSV Specialist (H/F)
CSV Specialist (H/F)
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Job Description
Looking to join a fast-growing company Ready to take a quality step forward in your professional journey Would you like to be part of a company offering numerous development opportunities in a multicultural and international environment
This opportunity is based at our production site in Brussels.
Our department
You will join the Qualification/Validation Department under the supervision of the Computerized Systems Validation (CSV) team lead within a dynamic team of 8 skilled professionals.
Role
As a CSV Specialist you will help ensure regulatory compliance of computerized systems related to production. Your main responsibilities will include:
- Execute validation projects for production equipment laboratory automated instruments and systems while contributing to the equipment lifecycle (validation review implementation).
- Create and support validation deliverables such as project plans impact assessments user requirements test strategies risk assessments protocols SOPs periodic reviews and system decommissioning activities.
- Contribute to remediation and data integrity projects ensuring compliance with US EU and other regulatory requirements while respecting internal procedures and EHS standards.
- Collaborate with production IT and laboratory teams to successfully carry out validation projects and effectively implement the validation program.
- Foster a culture of continuous improvement by identifying areas for process optimization and actively contributing to their implementation.
Required Qualifications:
- You have a technical or scientific background (bachelors or masters degree).
- You have experience in CSV or equipment qualification ideally in the pharmaceutical industry.
- You have a solid understanding of computerized systems and an interest in IT.
- You ideally possess knowledge of GMP and associated regulatory requirements.
- You will work in an international environment so you are able to understand and communicate in English both verbally and in writing.
- You have excellent interpersonal and communication skills and you enjoy collaborating effectively in a team setting.
- You are detail-oriented autonomous proactive and organized.
Working at Novo Nordisk
End of 2024 Novo Nordisk acquired the manufacturing site Catalent Belgium SA. The site is now part of Novo Nordisk and has begun the transition to become a fully integrated Novo Nordisk manufacturing site. To advance the integration the Brownfield Site Integration team for Brussels (BSI Brussels) has been established with the responsibility for local integration and capacity maximization in collaboration with the local team.
Novo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. Thats why we make room for diverse life situations always putting people first. We value our employees for the unique skills they bring to the table and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves and its a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 63400 employees. Together we go further. Together were life changing.
Want to know more
Contact
Apply directly on our website.
Application Deadline
The position is available immediately.
At Novo Nordisk we recognize that aspiring to be the best company in the world is no longer enough. We must aspire to be the best company for the world which we know is possible only with talented employees with diverse ideas backgrounds and cultures. We are committed to fostering an inclusive culture that celebrates the diversity of our employees the patients we help and the communities we serve.
We are committed to an inclusive recruitment process and equal opportunities for all candidates. We are happy to discuss flexible working arrangements depending on the role and business needs.
Required Experience:
Unclear Seniority
Employment Type
Full Time
