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 over 500 professionals operating from 6 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 <Enter Work base>, we are looking for a Validation officer / Validation engineer
WHAT YOU WILL WORK ON
As a validation officer / validation engineer you are involved in software/hardware lab automation and qualification/validation. In general, involvement in qualification of common computerized systems.
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.
YOUR KEY RESPONSIBILITIES
- Creation of user requirements specifications together with key users
- Performing risk assessments for using equipment and software
- Creation of test scripts for qualification/validation of equipment and software
- Execution of test scripts and documentation of test results
- Writing qualification/validation reports
- Review of qualification/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
- Writing/Review/improvement of procedures
- Provide support during audits and inspections
- Provide local support for a global computerized system application.
YOUR PROFILE LOOKS LIKE/ RESEMBLES
- 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
- We love creative thinking and pro-activeness
WHAT WE OFFER
- A true learning environment where you will have the ability to grow your skills
- A rapidly developing and growing international company with an attractive 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
- 30 days holiday a year
- Fruit & Fitness possibilities
Ready to apply? Please click on the application button on the website of Ardena.
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.