Job Description

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 750 professionals across six 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 Business Unit based in Oss, we are looking for a Validation Engineer

WHAT YOU WILL WORK ON

The Validation Engineer is responsible for the timely qualification and validation of production equipment, utilities and facilities. He/she ensures that they stay in validated state during its complete lifecycle, adhere to Quality Management System (QMS) and consistent with emerging/existing corporate & regulatory guidelines.

YOUR KEY RESPONSIBILITIES

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

• You will perform and supervise validation activities

• You will manage the entire installation process for the equipment at the production location

• You will set up annual maintenance, calibration and validation plans

• You are responsible for the Periodic (Re)Validation Reviews (PVR) for the equipment

• You will assess changes of validated systems

• You keep yourself up to date with the latest developments and insights

• You will report directly to the Director Facilities and Material Logistics

• You will closely work together with Production, Process R&D and QA.

YOUR PROFILE LOOKS LIKE/ RESEMBLES

• You have a Bachelor’s degree in Chemistry or Chemical Engineering or comparable level through experience

• You have at least 3 years of experience in the pharmaceutical industry

• You have experience with process equipment, utilities and facilities

• You have experience in cGMP guidelines and validation principles

• You feel comfortable in a dynamic and changing environment

• You like to learn and develop yourself

• You are flexible, a problem solver and a team player

• You have an analytical mindset and you are stress resistant

• Experience with CSV/CSA is desirable and considered an advantage

• You have good communication skills and are fluent in both Dutch & English (written as well as spoken)

• You are pragmatic, customer focused, pro-active, a team player and able to work under pressure.

WHAT WE OFFER

At Ardena, we recognize that our people drive our success. We offer:

✔ A competitive salary with a tailor-made benefits package, including: option to buy extra leave, standard travel allowance, bonus plan.
✔ Flexible working hours and 30 days of paid holiday per year
✔ 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

Want to know more? Contact Roy van de Camp at hr.nl@ardena.com.

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