Validation Engineer

  • Oss, NL
  • 2 weeks ago

About Ardena

Ardena is a reputed contract partner providing drug substance and drug product development, manufacturing, logistics and bioanalytical services to pharmaceutical customers globally. In parallel, we compile the regulatory dossier for our customers to fast track their product towards compliance. Ardena has a niche expertise in development and manufacture of nanomedicines and nanocrystalline products. Every day, we guide companies through the hurdles and challenges of drug development. Our integrated service offering helps to streamline the drug’s progress to clinic and beyond, to reduce risk and timelines, and to facilitate a seamless flow of information.

We have a dedicated team with over 200 professionals divided over 6 sites in Belgium (Gent) and The Netherlands (Amsterdam, Oss, Assen), Sweden (Södertälje), and Latvia (Riga). Ardena has an open culture. Team-spirit and entrepreneurship are important values in our company.

As a dynamic CDMO, we offer exciting career opportunities for skilled and motivated people that want to work in a fast-growing business, in the global pharmaceutical industry. Do you want to work in a challenging contract research and development environment, where experts come together to make new drugs a reality? Are you able to handle complex projects? Ardena offers ample opportunities to develop your scientific and technical skills as well as your managerial and commercial skills. The products that Ardena develops for her customers are generally technically highly complex and consequently offer interesting scientific challenges for our team.

In Oss, The Netherlands, Ardena has a business unit specialized in chemical process and analytical development and cGMP manufacture of Active Pharmaceutical Ingredients (API) and nanomedicines (formerly ChemConnection).

For the Oss site we are looking for a

Validation Engineer

Job Description

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.

The main role of the Validation Engineer will be:

  • Drawing up validation project plans and validation documents according to international GMP guidelines;
  • Contributing to the drawing up of user requirements;
  • Performing and supervising validation activities;
  • Performing risk analyses on equipment;
  • Setting up an annual maintenance, calibration and validation plan;
  • Managing the entire installation process for the equipment at the production location;
  • Responsible for the Periodic (Re)Validation Reviews (PVR) for the equipment;
  • Assessing the validity of the validation on changes of validated systems;
  • Writing of annual reports.

Qualifications

  • At least a Bachelor’s degree in Pharmaceutical, Mechanical, Process, or other relevant training;
  • At least 3 years of experience in the pharmaceutical industry and in validating equipments, utilities and facilities;
  • Sound knowledge of GMP, laboratory and pharmaceutical validation principles;
  • Knowledge of maintenance and validation requirements of pharmaceutical systems;
  • Excellent communication skills in both Dutch and English (oral and technical written);
  • Pragmatic, innovative, customer focused, pro-active, hands on and a team player;
  • Ability to seek collaboration in a fast-paced environment, good communicator;
  • Self-starter, solutions oriented and quality driven;
  • Strong project management skills, ability to work under time pressure.

We offer

A challenging job in an international environment within the most innovative industry branch: the pharmaceutical industry.

Do you have questions?

For questions please contact Kees-Jan Booy, Director Material Logistics and Facilities by email: keesjan.booy@ardena.com

Do you want to apply?

Your response to the vacancy, including a motivation letter and CV, can be directed to Joleen Schoenmakers by email: info.oss@ardena.com