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 7 company sites in 5 countries. (Belgium, the Netherlands, Latvia, Sweden and Spain). In recent years we have taken over several other organizations which are complementary to each other and created One Ardena Group. We currently have approximately 480 people working for us. We 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 facilities, the equipment, utilities and facilities needs to be in qualified state. The Validation Engineer is responsible for timely (re)qualification of these systems and the qualification of new equipment. You ensure that they stay in qualified state during the complete lifecycle. You have to adhere to the Quality Management System (QMS) and be consistent with regulatory guidelines.
YOUR KEY RESPONSIBILITIES
- You will draw up qualification project plans and documents according to international GMP guidelines
- You will perform and supervise qualification activities
- You will manage the entire installation process for the equipment at the production location
- You will set up annual maintenance, calibration and qualification plans
- You are responsible for the periodic reviews for the equipment
- 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.
- 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/ nutrition industry
- You have experience with process equipment, utilities and facilities
- You have experience in cGMP guidelines and qualification 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 are true to our values
- 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: firstname.lastname@example.org, Tel: 0614806316
Ready to apply? send us your cv and motivation letter via our website ardena.com/careers.
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.