About us

As a leading contract research, development, and manufacturing organization (CRDMO), 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, bioanalytical services, clinical logistics, 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), Sweden (Södertälje), Spain (Pamplona), and the US (Somerset, New Jersey). 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.

For the Ardena Bioanalysis Division based in Assen and Oss, The Netherlands, we are looking for a:

                                             Associate Validation Engineer
                                             (32-40 hours per week)

Our bioanalytical laboratory is a highly specialized, GLP-compliant facility offering a wide range of bioanalytical services to global pharmaceutical partners, from early drug discovery to Phase IV clinical studies. Our mission is to provide precise quantitative and qualitative analyses of drugs and biomarkers in biological matrices using cutting-edge techniques, including LC-MS/MS, ligand-binding assays (ELISA), qPCR, and flow cytometry.

Our growing team of bioanalytical scientists brings expertise across diverse fields, covering small molecules, peptides, cells, and proteins—such as antibodies, antibody-drug conjugates, oligonucleotides, and nanoparticles.

Your Role

As an Associate Validation Engineer, you will play a crucial role in equipment / computerized system validation. You will closely work with key users to develop, review and maintain essential documentation and procedures throughout the lifecycle of computerized systems and equipment in the laboratory, from installation to retirement.

Your Responsibilities

• Collaborating with key users to define User Requirements Specifications.
• Performing risk assessments for laboratory equipment and software.
• Developing test scripts for equipment and software validation.
• Execution of test scripts and documentation of test results.
• Documenting and reviewing test results and validation reports.
• Reviewing validation dossiers and equipment files.
• Managing change control procedures, including change requests, close outs, and retirements.
• Conducting periodic reviews, audit trail reviews and user reviews of computerized systems.
• Reviewing and improving procedures to ensure compliance and efficiency.
• Supporting audits and inspections by internal and external stakeholders.

Profile Profile

• Eligibility to work in the Netherlands (valid work permit or EU citizenship required).
• Experience working in a GxP-compliant environment.
• Preferably, knowledge of GAMP and 21 CFR Part 11regulations.
• Hands-on experience with computerized system validation.
• A vocational college (Dutch MBO) or bachelor's degree (Dutch HBO) in a relevant field.
• Strong communication and analytical skills, with the ability to translate user requirements into validation strategies.
• A quality-focused mindset with keen attention to detail.

What We Offer

• Salary range: € 3500,- to € 4500,- gross per month (based on a 40-hour workweek)
• A true learning environment where you will have the ability to grow your skills
• A dynamic working environment with friendly and enthusiastic colleagues
• A company culture with open communication, where employee well-being is highly valued
• An attractive remuneration package
• Flexible working hours to support work-life balance.

Ready to apply? Please click on the application button.

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.