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 services. We strongly believe that our multidisciplinary approach can accelerate the drug development and approval process. By seamlessly integrating our services, we’re able to better mitigate development risks and ultimately reduce time-to clinic.

Ardena is a rapidly growing international orientated organization in the industry, with 6 company sites in 4 countries. (Belgium, the Netherlands, Latvia and Sweden). In the past 3 years we have taken over several other organizations which are complementary to each other and created One Ardena Group. We currently have 300 people working for us and an annual revenue of 44 million (2020) and have realized an average growth of 15% on annual basis over the past 3 years and we have the ambition to continue this growth.

The Ardena business unit in Oss is specialized in chemical process and analytical development and cGMP manufacture of Active Pharmaceutical Ingredients (API) and nanomedicines For this Business Unit we are looking for a

Validation Engineer (FT)

WHAT WILL YOU WORK ON
For cGMP manufacturing in our production plant the equipment, utilities and facilities needs to be in qualified state. The Validation Engineer is responsible for the timely qualification and validation of these systems. You ensure that they stay in validated state during the products/ utilities complete lifecycles. You have to adhere to the Quality Management System (QMS) and be 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 validated state on changes of qualified systems
• You keep yourself up to date with the latest developments and insights on QMS and Quality Assurance
• You will be joining the facility management team and will report directly to the Director Facilities and Material Logistics. The team consists of a service engineer and two facility managers
• 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/Chemical Engineering or Mechanical Engineering or a comparable level through experience
• You have at least 3 years of experience in the pharmaceutical or food/ nutricion 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 are accurate and have an analytical mindset
• You have good communication skills and are fluent in both Dutch & English (written as well as spoken)
• You are pragmatic, customer focused, pro-active and a team player

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 love creative thinking and pro-activeness
• We are true to our values

Next to that we also offer of course:
• An attractive remuneration package
• Flexible working hours
• 28 days of holiday per year
• Fruit & Fitness possibilities
• The office is easy to reach by public transport

If you like to have more information about the role, please do not hesitate to contact Kees-Jan Booy, email: keesjan.booy@ardena.com, Tel: 0614806316

Ready to apply? send us your cv and motivation letter via our website ardena.com/careers or email at info.oss@ardena.com

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 Netherlands will not be given a status update.

Agency calls will not be appreciated.

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