Computerized System Validation Engineer (CSV)

Vacancy details

General information



Publication date


Position description



Job title

Computerized System Validation Engineer (CSV)


Fixed term contract

Job description

For one of our clients in the pharmaceutical industry, we are looking for a medior/senior Computer System engineer (CSV).

The CSV role is computer System Validation, focused on quality and computer/automation or technical basic knowledge of the systems.



  What will be your tasks?


-        Ensure the execution or revision of the required pre-tests before starting the final implementation of the new processes.

-        Coordinate all GMP documentation necessary for change control management (VP - TCD - VSR

- QAGMP authorization - QAGMP approval - external contingent documentation, etc.).

-        Drafting of URS, FAT, SAT, IQ, OQ, PQ validation protocols and analyzing the results during PQ passages.

-        Ensure the planning of validations in partnership with the C&M/QA departments and production

-        Ensure communication with the production team.

-        Ad hoc assemblies/resources for validation.

-        Ensure the operational management of technicians dedicated to validations.

-        Ensure all deviations related to the implementation of the change.

-        Track QC results for each validation cycle.

-        Ensure timely collection/transfer of approved local documents to RA department to ensure timely submission of case.

-        Ensure the review of the preparation of the file in partnership with the QA before the submission of the file to the authorities.







Fundamental research • Microsoft Office • Biotechnology • Project management • Engineering • Teamwork • Vp • Tcd • Vsr • Urs • Fat • Pharmaceutical sector • Validation of IT systems • C&m • CAPA • Change control • IOQ • PQ • IQ • Validation • Good Practices (GxP) • Verification and Validation

•  Good Manufacturing Practices (GMP) • FDA Good Manufacturing Practices • Gmp

Business Industry

Life sciences


  Your skills

-        Degree in engineering or scientific bachelor (bio engineer, electronics, computing, automation, industrial engineer, IT...)

-        1 year experience on pharmaceutical industry or 1 year training

-        Good communication skills (close interaction with stakeholders)

-        Problem-solving skills

-        Motivation to provide result on time

-        Determines how to move the project forward

-        Analytical thinking, requests and execution, problems, project plan, timelines...

-        Interact closely with the stakeholders, coordination

-        Good communicator between stakeholders Readiness to demonstrate a proactive attitude

-        Good verbal and written communication skills

Position location

Job location

Europe, Belgium



Candidate criteria

Level of experience

3 to 5 years