Dutch-Speaking Qualification & Validation Engineer

A leading global pharmaceutical organisation are looking for experienced Dutch-speaking Qualification & Validation Engineers to join their team in the Netherlands.

MUST HAVES:

- Dutch
- Validation/Qualification experience - sterilisation, freeze-drying, cleanroom and filling processes
- Decommissioning - nice to have

THE FUNCTION

The project involves decommissioning of all associated production equipment, process, and utilities in the aformentioned areas. There are also changes to currently installed building-related systems.

In this position, you will be responsible for performing the following tasks in a precise manner:

- Drafting of final qualification protocols
- Planning and coordinating the resources required for these qualifications
- Implement and execute these protocols by means of measurements for said devices
- Reporting of these measurements, preparation of final qualifying report
- Implement a written periodic review
- Implement a Retirement Plan and the result yields a Retirement Report
- Keeping properties and group scheduling work for the holding and conducting metrics accordingly
- The update of change control activities for the above tasks
- Archiving the generated documentation correctly and ready for steaming finished the archive at a later stage

THE FOLLOWING TASKS/RESPONSIBILITIES ALSO ARE PART OF THE FUNCTION:

- Implement an RCA and/or CAPA caused to defects in the project. Here, a high degree of knowledge of the processes in progress expected o.a sterilisation, freeze-drying, cleanroom and Filling processes
- Qualification in relevant field
- HBO Technical
- Experience in project work
- Relevant work experience in the pharmaceutical industry (GMP)
- Experience with aseptic manufacturing is a plus
- Experience in the operation of cleanrooms is an advantage
- Able to work independently and in a team
- Results oriented, innovative capacity and driven to improve
- Excellent communication and social skills at different levels in word and writing
- Writing and speaking skills in English
- Affinity with performing physical measurements on process equipment and systems
- Driven and experienced in using Office software