About the opportunity

Join us as a Validation Engineer to support our GMP QC Lab Team . In this role you will be responsible for performing qualification, validation and engineering activities in a GxP (GMP / GLP) environment. Moreover you will manage multiple lab equipment qualification and computerized systems validation projects.

If you have experience with lab equipment and computer systems we would be very interested to see your application.

About Sanofi Ghent

Sanofi Ghent is engaged in the development of NANOBODY® molecules, proprietary therapeutic proteins based on single-domain antibody fragments, which can be easily engineered into multi-valent and multi-specific molecules. NANOBODY® molecules have potential uses in the treatment of a range of serious and life-threatening human diseases and Sanofi Ghent advances a portfolio of Nanobody-based therapeutic programs in several major disease areas, including inflammation, haematology, immuno-oncology and oncology.

In this role you will….

• Perform activities in a GxP lab environment in close contact with the Good Manufacturing Practice (GMP) Quality Control (QC) Lab and Good Laboratory Practices (GLP) Pharmacology lab
• Manage multiple lab equipment qualification and computerized systems validation projects. The planning is discussed and aligned within the Validation team and involved stakeholders
• Provide support to the GMP QC Lab in terms of equipment calibration, (re)qualification, preventive maintenance and repair
• Write, review and finalize qualification and validation deliverables (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 GxP guidelines and a GxP 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
• Software and IT affinity
• 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, continuous improvement, quality, accuracy and detail
• Oral and written fluency in Dutch and English

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.