About us

Ardena is a leading Contract Development and Manufacturing Organization (CDMO) for the pharmaceutical industry. We help pharmaceutical companies, from small Biotech to large Pharma companies, bring their products to market through clinical trials. We offer a comprehensive and integrated portfolio of drug development services.

Ardena is a rapidly growing internationally oriented organization with a dedicated team of more than 750 professionals operating from 6 sites in Belgium, the Netherlands, Sweden, Spain and the United States. Ardena has an open and transparent culture: team spirit, an open mentality and ownership are important values in our company.

In recent years, Ardena has made a number of successful business acquisitions. These companies are complementary to each other and together form the One Ardena Group. We have achieved substantial growth every year for the past three years and our ambition is to continue this growth in the coming years. Do you want to work in a challenging contract development and manufacturing organization, where experts come together to create innovative medicines for unmet medical needs? Would you like to further develop Ardena by becoming our next colleague? Then we may have the perfect career move 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 the validity of the validation on 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
• 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

• 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
• Free Fruit & Fitness possibilities
• An office that is easy to reach by public transport.
   

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.