About us

At Ardena, we’re helping shape the future of medicine. Our teams work on the development of innovative and complex therapies that can improve the lives of patients around the world.

As a global Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO), Ardena partners with pharmaceutical and biotech companies to turn scientific ideas into real treatments. From early development to manufacturing and regulatory support, we help bring new medicines to market faster and with the highest quality standards.

With more than 750 colleagues across Europe and the United States, Ardena offers expertise in drug substance and drug product development, manufacturing, bioanalytical services, clinical logistics, fill & finish, and CMC regulatory support.

But what truly makes Ardena special is our people. We are a science-driven and people-focused company where collaboration, innovation, and curiosity are encouraged.

We offer an international environment where you can learn, take initiative, and grow your career across teams, functions, and locations. Our way of working is guided by our CARE values: Communicative, Accountable, Reliable, and Excellent. These values shape how we collaborate, solve challenges, and support each other every day.

At Ardena, you’re not just building your career — you’re helping build the future of medicine.

For the Ardena Business Unit Drug Product Development and Manufacturing (DDM) based in Mariakerke (Gent, Belgium), we are looking for a

Validation Engineer

Ardena Gent guides a worldwide portfolio of customers through the processes of formulation and analytical development, preparation of regulatory dossiers and the manufacturing and labeling of early-phase clinical materials according to GMP appropriate standards.

The Validation and Maintenance group plays a key role in ensuring all equipment and computerized systems are well maintained and in the appropriate qualification or validation status during the manufacturing of investigation medicinal products (IMPs).

YOUR KEY RESPONSIBILITIES

The Validation Engineer is responsible for day-to-day support in terms of equipment-issues and closely monitoring and implementing the Validation Master Plan.

· Provides hands-on technical assistance on equipment (laboratory testing equipment like LC, dissolution, balances, .... and production equipment being tabletting machine, blender, weight sorter, ....) and computerized systems-related issues (Empower, LabX, firmware of the equipment, ...).

· Is first contact for suppliers: requests and negotiates on offers, coordinates equipment interventions and qualifications, performs follow-up and reviews the supplied documentation.

· Drafts protocols and reports for initial and periodic qualification (validation) of equipment (computerized systems) for use in GMP.

· Drafts or reviews procedures related to equipment and computerized system and ensures their strict implementation.

· Manages the maintenance and qualification planning of the equipment according to the qualification schedule and ensures timely execution using LIMS as Validation Master Plan.

· Performs and/or coordinates periodic equipment maintenance and qualification.

· Documents changes, CAPAs and investigations related to equipment and computerized systems.

· Assists in (internal) audits.

YOUR PROFILE

· You have a strong affection with techniques, equipment and computerized systems.

· You have knowledge of GMP quality system and regulatory requirements, in particular in relation to equipment and computerized systems.

· Experience in pharma is essential; you previously gained hands-on experience while working in a laboratory or production environment and you have a strong affection for writing procedures and protocols.

· You are solution driven, keeping timelines and budget in mind.

· You are continuously looking for improvement.

· You have strong communication skills, able to listen and analyze a quality issue and explaining the proposed solution in an accurate manner.

· You are able to manage multiple projects and tasks – also when performed by other team members - and roll out a strict follow-up on on-going activities.

· You have a preference for documentation and like to organize.

· You demonstrate flexibility and are willing to join our on-call duty system, which is organized on a rotating basis.

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 "WE CARE" values

· An attractive remuneration package

· Flexible working hours

· 32 days holiday a year