Computerized Systems Validation (CSV) Specialist/Engineer/Analyst

Introduction to Ardena

As a leading Contract Development and Manufacturing Organization (CDMO), Ardena partners with pharmaceutical companies of all sizes—from emerging biotech to global industry leaders—united by the mission to help biopharma innovators navigate drug development with precision, quality, and speed, bringing their molecules from discovery to the clinic and market. Our fully integrated services span drug substance and drug product development, manufacturing, nanomedicine, clinical logistics, bioanalytical services, state research, fill & finish, and CMC regulatory support.

With a rapidly growing international footprint, Ardena is home to over 700 professionals across five strategic locations—Belgium (Ghent), the Netherlands (Oss and Assen), Spain (Pamplona), and Somerset, New Jersey (the US). Our open and transparent culture is built on collaboration, ownership, and innovation, guided by our We CARE values. We foster a communicative environment where mutual respect, accountability, and excellence empower our team.

We are looking for skilled and motivated professionals eager to grow their careers in an exciting and fast-paced environment. Whether you’re an experienced expert or just starting out, Ardena provides a dynamic workplace where you can contribute to meaningful drug development projects, expand your knowledge, and be part of a global team committed to making a difference. As an international organization, we help you navigate a career path that expands your possibilities beyond borders, opening doors to personal and professional growth without limits. Your potential to grow is limitless with us.

If you are ready to take on new opportunities, work alongside industry experts, and contribute to the future of medicine, Ardena is the place for you.
 

For the Ardena Corporate department we are looking for a

Computerized Systems Validation (CSV) Specialist/Engineer/Analyst

WHAT YOU WILL WORK ON

Within our fast-growing environment, we are continuously striving for an optimal level of processes and automation. In this specific role you will be responsible for the validation of all GxP-compliant computerized systems.

You will join the corporate CSV team in the building of a global, GxP-compliant, computerized systems environment.

With the support of the Ardena IT department, it is your mission to guarantee the quality of these software systems in line with GxP guidelines.

YOUR KEY RESPONSIBILITIES

• You take part in setting up and documenting a risk-based validation strategy.

• You will draw up validation project plans and validation documents according to international GxP guidelines.

• You review the current procedures and adjust or rewrite where necessary.

• You assure that data integrity requirements are met.

• You stay informed about emerging validation regulations and validation testing practices.

• You provide technical assistance related to current US FDA and EU validation requirements.

• You monitor compliance with the relevant regulations such as CFR 21 Part 11 / Annex 11.

• You are jointly responsible for determining the impact of changes and for drawing up deviations and CAPA.

• You will closely work together with colleagues from the QA departments, the IT department, validation engineers and others across different departments depending on the project.

YOUR PROFILE LOOKS LIKE/ RESEMBLES

• Bachelor’s degree in a scientific direction (Chemistry, Chemical Engineering, Biotechnology, Pharmacy, IT) or a comparable level through experience

• At least 5 years of experience in Health & Life sciences, pharmaceutical or food/ nutrition industry

• Experience in common standards and guidelines (GxP, GAMP5, 21CFR Part11, ISO, etc.) and you are familiar with terms like QMS, Data integrity, CAPA, LIMS, CDS.

• Advise and solve validation problems related to projects, process development, risk mitigation, etc.

• Willing and able to travel to several locations to support and work with the local teams. (Travel 20% of the time)

• Comfortable in a dynamic and changing environment

• Willing to learn and develop yourself

• Flexible, a problem solver and a team player

• Accurate and an analytical mindset

• Interest in AI

• Good communication skills English (written as well as spoken)

• Dutch and Spanish are beneficial

WHAT WE OFFER

• ✔ A competitive salary
  ✔ Flexible working hours 
  ✔ A dynamic, international work environment with career growth opportunities
  ✔ Access to Ardena Academy, our internal learning platform for professional development
  ✔ A chance to contribute to groundbreaking drug development projects that make a real impact

HOW TO APPLY

Ready to start your career path with Ardena? Click the application button and join us in shaping the future of drug development!

Only candidates eligible to work in the EU will be considered for the position. Unfortunately, given the high volume of applications we receive for our vacancies, these professionals (not entitled to work in the European Union) will not be given a status update. Agency calls will not be appreciated.