Overzicht


  • Reviewing and writing qualification documents (URS, protocols/reports, etc.);

  • Works with moderate work direction and is skilled and knowledgeable to the position;

  • Must have sufficient knowledge of the laboratory equipment software;

  • Execute system administrator tasks according to procedures;

  • Ability to support laboratory equipment qualification;

  • Ability to support third party engineers on preventive maintenance laboratory equipment;

  • Knowledge of Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP) is preferred;

  • Knowledge of image and incremental backups;

  • Knowledge of installation of patches and establishment of workarounds (mitigation of vulnerabilities);

  • Knowledge of mitigation laboratory equipment related ICT problems.

In 1923, Saal van Zwanenberg started Organon, where at that time pancreatic porcine insulin was purified. It was the start of over 90 years of innovative pharmaceutical production in Oss. Approximately 1,500 colleagues currently work on the production and development of medicines at two locations.


Quality Operations (QO) at MSD Biotechnology operations Oss has the following sub-functions: Quality Assurance, Quality Systems, Quality IPT, Quality Control and Biological Critical Reagents HUB. The QO Department must ensures adequate quality systems are in place to support the manufacture, packaging, testing, storage, and distribution of MMD products according to MMD Policies, Guidelines & Procedures and regulatory requirements by appropriate oversight and monitoring.


Provides day to day support for Biotech Operations, raising concerns if needed or directing users to do so. In co-operation with functional areas and in line with quality procedures and guidelines, support the handling of deviations, including implementation of CAPA’s. Partner with internal and global groups for technical issues resolution related to investigations or system issues.

The Quality Engineer is responsible for classification of laboratory systems, whether computerized. As a Quality Engineer you have close contact with the internal customers. You will be working on verification of qualification documents produced by outside companies.


  • Minimum education requirement is Bachelor with emphasis experience in working with laboratory equipment;

  • Knowledge and experience with automated ICT is mandatory;

  • Must be proficient in Windows XP and Windows 7 environments;

  • Must have an analytical mind-set;

  • Ability to be independent, solution-oriented and customer friendly;

  • Ability to write, review and provide ICT knowledge for test protocols;

  • Ability to review and understand internal, government and international testing specifications;

  • Ability to provide ICT knowledge for system changes;

  • Ability to provide ICT improvement processes;


  • Must be able to work in a team environment.

Vacature type:
Categorie: Engineering
Ervaring: Full-time

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