Computerized System Validation Engineer (CSV)

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.

  Keywords

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

  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