About us

Ardena is a leading contract research organization serving the pharmaceutical industry. We support pharmaceutical companies—from biotech startups to large pharmaceutical corporations—in bringing new drugs to the clinic and the market. We offer a comprehensive and integrated portfolio of services for drug development, manufacturing, and bioanalysis.

Ardena is a rapidly growing, internationally oriented organization with a dedicated team of over 500 professionals operating across five locations in Belgium, the Netherlands, Sweden, and Spain. We pride ourselves on fostering an open and transparent culture, where team spirit, an open mindset, and ownership are core values.

Our laboratory in Assen is a highly specialized and innovative facility that offers a wide range of bioanalytical services to the global pharmaceutical industry, from drug discovery research through to Phase IV clinical studies. In our recently expanded and renovated GLP-compliant laboratory, our mission is to provide quantitative and qualitative analyses of all types of drugs, as well as biomarkers in biological matrices, using techniques such as LC-MS/MS, ligand-binding assays (ELISA), qPCR, and flow cytometry.

Our enthusiastic team of approximately 100 bioanalytical scientists brings expertise across a diverse range of areas, from small molecules and peptides to cells and proteins, including antibodies and antibody-drug conjugates, oligonucleotides, vaccines, and nanoparticles.

For the Ardena Bioanalysis Business Unit based in Assen, The Netherlands, we are looking for a

Validation Officer / Engineer

Your key responsibilities 

As a validation officer / validation engineer you are involved in software and hardware lab automation.
Together with key users you will be involved in the creation and review of all necessary documentation and procedures during the lifecycle of computerized systems and equipment in the laboratory, from the installation to retirement. Amongst others, you will be responsible for the following activities:

• Creation of user requirements specifications together with key users
• Performing risk assessments for using equipment and software
• Creation of test scripts for validation of equipment and software
• Execution of test scripts and documentation of test results
• Writing validation reports
• Review of validation dossiers and equipment files
• Performing change control procedures (change requests, close outs, retirements
• Periodic review, audit trail review and user review of computerized systems
• Review/improvement of procedures
• Provide support during audits and inspections
  

Your profile looks like

• You have experience with GxP
• Experience with GAMP and 21 CFR Part 11 is preferred
• You have experience with computerized system validation
• You have medium or higher professional level of education (vocational college or bachelor's degree (Dutch MBO/HBO))
• You have strong communication skills and are able to listen in order to analyze requirements and risks
• You are proactive
• You are quality minded and pay attention to detail
  

What we offer

• Salary range: € 3000,- to € 5000,- 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
  

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.