Senior Validation Engineer (Laboratory), Belgium

08/07/21

Location

Technologiepark-Zwijnaarde 21, Gent, Belgium

Function type

Quality Control

Vacancy

About the Opportunity

Join Ablynx, a Sanofi company as a Senior Validation Engineer responsible for the coordination and implementation of qualification, validation and system operational life cycle activities in a GxP environment.  

Part of your role will be to write and execute the validation deliverables for laboratory equipment and computerized systems as a member of the Validation team (part of the GMP Unit).

This full-time permanent position will be based in Ghent, Belgium.

About Ablynx

Ablynx, a Sanofi company, is engaged in the development of Nanobodies®, proprietary therapeutic proteins based on single-domain antibody fragments, which combine the advantages of conventional antibody drugs with some of the features of small-molecule drugs.

Nanobodies have potential uses in the treatment of a range of serious and life-threatening human diseases. Ablynx advances a portfolio of Nanobody-based therapeutic programs in several major disease areas, including inflammation, haematology, immuno-oncology and oncology.

About growing with us

In this role you will…

  • Perform activities in a GxP environment in close contact with the Good Manufacturing Practice (GMP) Quality Control (QC) Lab

  • Manage multiple and complex computerized systems validation and equipment qualification projects. The planning is discussed and aligned within the Validation team and involved stakeholders

  • Write, review and finalize the validation documentation (URS, RA, protocols, reports, trace matrix, requalification, periodic review, non-conformities) for new or existing systems (lab equipment, computerized systems) used in the GxP environment

  • Perform and review (re)qualification and calibration of systems used in the GxP environment

  • Initiate, review and follow-up on Quality Events to ensure completion within due date

  • Interact with external and internal suppliers in function of design, validation, implementation, maintenance and calibration of systems

  • Optimize and maintain operational procedures on validation, calibration and the life cycle of systems based on regulations and guidance documents

  • Organize training sessions on the operating instructions for personnel working with the system

  • Coach, motivate and support your Validation team members in all of the above tasks

About you

Qualifications/ Education & work experience

  • Master in a relevant field of sciences

  • Experience with GMP guidelines and a GMP working environment

  • 3+ years of experience in (computerized) systems validation and/or in lab equipment qualification

  • Knowledge of Data Integrity, 21 CFR Part 11, USP<1058> and GAMP guidelines

  • Experience in project management of validation projects – advantageous

  • Software and IT affinity – advantageous

  • Excellent communication, collaboration skills and ability to work cross-functionally

  • Team player, enthusiastic, independent and self-motivated

  • Practical hands-on mentality

  • Sense for problem solving, initiative, quality, accuracy and detail

  • Oral and written fluency in English, Dutch is an asset

Inspire your Journey: what Sanofi can offer you:

  • An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team

  • An attractive, market-oriented salary aligned with your qualifications and including social benefits above average (e.g. company pension plans, health management)

  • An individual and well-structured introduction and training when you onboard

  • You can create your own career path within Sanofi. Your professional and personal development will be supported purposefully

  • As a globally successful and constantly growing company, Sanofi provides international career paths as well

This is our Sanofi. Discover yours.

If you feel you have the required experience please apply, alternatively contact sandra.rombi@sanofi.com directly for more details.

https://www.sanofi.com/en/careers/

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