(Senior) Validation Engineer
About this opportunity
Ablynx, a Sanofi company is welcoming applications for the role of (Senior) Validation Engineer for our GMP Unit.
As (Senior) Validation Engineer, you will be responsible for coordination and implementation of qualification, validation and engineering activities in a GxP (GMP / GLP) environment.
Based on the level of experience and expertise, this position could be graded as a Senior Validation Engineer or as a Validation Engineer.
About Ablynx, a Sanofi Company
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.
- You perform your activities in a GxP environment in close contact with the GMP QC Lab and GLP Lab;
- You enjoy managing multiple and complex validation and qualification projects. The planning is discussed and aligned within the Engineering team and involved stakeholders;
- You 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;
- You perform and review (re)qualification and calibration of systems used in the GxP environment;
- You initiate, review and follow-up on Quality Events to ensure completion within due date;
- You interact with external and internal suppliers in function of design, validation, implementation, maintenance and calibration of systems;
- You optimize and maintain operational procedures on validation, calibration and the life cycle of systems based on regulations and guidance documents;
- You write, review and maintain operating instructions for systems or software;
- You organize training sessions on the operating instructions for personnel working with the system;
- You assist in technical problem solving and maintenance activities;
- You coach, motivate and support your Engineering team members in all the above tasks.
- Master in a relevant field of sciences;
- Experience with GMP guidelines and a GMP working environment;
- At least 3 years of experience in (computerized) systems validation and/or in lab equipment qualification;
- Knowledge of Data Integrity, 21 CFR Part 11 and GAMP guidelines;
- Team player, enthusiastic, independent and self-motivated;
- Excellent communication skills are required;
- Practical hands-on mentality;
- Sense for problem solving, initiative, quality, accuracy and detail;
- Excellent knowledge of English both in reading and writing;
- Fluency in Dutch is a nice to have.
It would be advantageous to have (not essential):
- Experience in project management of validation projects is an asset;
- Experience with any of the following equipment/techniques is a plus: LC, CE, Biacore, Karl Fischer, Casy, spectrophotometers, microplate readers;
- Fluency in Dutch is not essential but is a plus.
What Sanofi can offer you
- This is a challenging role with a lot of variation and a good balance between documentation and hands-on activities;
- We offer the change to learn by allowing you to own your projects and do a very deep-dive into them.
Empower Life Everyday
At Sanofi we work across human health from vaccines to rare diseases, and consumer healthcare. This creates opportunities to work across different areas to build a diverse and exciting career. Sanofi has the capabilities and resources to support your aspirations to fulfill your ambitions and be the best you can be.
Our purpose at Sanofi is to work passionately every day to understand and solve healthcare needs of people across the world. Our ambition is by 2025, to be a top 3 innovative, global and diversified human healthcare company. One that embraces transformative technologies and is focused on its area of excellence, which means we’re not there to try to solve everybody’s problems. We want to focus on those areas where we know we are making a difference.
The values we live by are teamwork, courage, respect and integrity.
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.