Ardena is a leading contract development organization for the pharmaceutical industry. We assist pharmaceutical companies, from virtual biotech to big pharma, in bringing their valued molecule(s) to the clinic and market. We provide a comprehensive and integrated portfolio of drug substance and drug product development, manufacturing, logistics and bioanalytical services.
Ardena is a rapidly growing international orientated organization with a dedicated team of about 480 professionals operating from 7 sites in Belgium, The Netherlands, Sweden, Latvia and Spain. Ardena has an open and transparent culture: team-spirit, an open mindset and ownership are important values in our company.
We are a dynamic drug developer offering exciting career opportunities to skilled and motivated people who want to work in a fast-growing market within the global pharmaceutical industry. Do you want to work in a challenging contract research and development environment, where experts come together to develop innovative drugs for unmet medical needs? Do you want to further develop Ardena and grow with us by becoming our next colleague? Then we might have the right opportunity for you.
For the Ardena Business Unit based in Assen, The Netherlands, we are looking for a
Validation Officer / Engineer
WHERE WILL YOU WORK
Ardena Bioanalysis (Assen, the Netherlands) is a highly specialized and innovative organization that offers a full range of bioanalytical services from drug discovery research up to phase IV clinical studies. In our recently expanded and renovated GLP compliant laboratory our mission is state-of-the-art quantitative analysis of all types of drug compounds, their metabolites, as well as biomarkers in biological matrices using LC-MS/MS, ligand binding assays and flow cytometry.
The expertise of our enthusiastic team of over 90 highly educated bioanalytical scientists varies from small molecules to proteins including antibodies, antibody drug conjugates, oligonucleotides, and vaccines.
Ardena is a knowledge driven organization. An enthusiastic highly qualified team collaborates in a professional and informal atmosphere.
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
YOUR PROFILE LOOKS LIKE/ RESEMBLES
- You have experience with GxP
- Experience with GAMP is preferred
- You have experience with computerized system validation
- You have medium or higher professional level of education (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
- A true learning environment where you will have the ability to grow your skills
- A rapidly International developing and growing company with an interesting services, product and customer portfolio
- A dynamic working environment with nice colleagues
- Open straightforward but also caring culture
- We are true to our values
- An attractive remuneration package
- Flexible working hours
- 28 days holiday a year
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.