Ingénieur(e) Procédés Down Stream Process M/F
- Pharmaceutique / Biotechnologique
Ingénieur(e) Procédés Down Stream Process M/F
Who are they?
At Sanofi, we pursue the miracles of science to improve people’s lives. In France, more than 20,000 passionate men and women tirelessly push their limits to transform the practice of medicine and improve patient health with drugs and vaccines.
The desire to advance science is our strength. We want to improve the health of populations and find new solutions for patients by combining scientific progress and advanced technologies.
In France, we provide more than 400 drugs, vaccines and health products, including 18 vaccines and more than 200 drugs of major therapeutic interest.
Sanofi’s roots are anchored in France where most of the Research and Development is located. In the French medical research landscape, we hold a central role and actively participate in the construction of a dynamic health sector.
To contribute to the world of tomorrow, three commitments guide our actions: access to care for the most vulnerable, inclusion of all through work and preservation of the planet. Nothing would be possible without the remarkable mobilization of our employees and partners.
Le contenu du poste libellé en anglais car il nécessite de nombreuses interactions avec l'étranger, l'anglais est la langue de travail.
Sanofi Vitry-sur-Seine, located 10 minutes from Paris, is one of the most innovative sites within the group with more than 2000 employees. With an ultra-modern multi-products cell culture and purification plant, the Biolaunch, the site gathers research, development and manufacturing of biological drug substances as monoclonal antibodies. Diversification continues to bring new products to Vitry-sur-Seine and the expanded site portfolio continues to create new opportunities.
The Global Manufacturing Sciences and Technology (MSAT) is a center of excellence in manufacturing and process sciences and as such is the keeper of the body of manufacturing process knowledge. It is a multi-disciplinary function that provides expertise in process and analytical sciences; manufacturing sciences, process modelling, trending and statistical analysis; process validation and technology transfer.
The Global MSAT organization is the seeding ground for technical and scientific talent that executes their work in matrix organization. Furthermore, the Global MSAT is providing cross-functional training and development and is the portal for collaboration with many different organizations including process development and operations.
In that scope, Global MSAT is responsible for
- Providing on-the-floor technical and scientific support
- Providing expertise in process/product-related investigations
- Overseeing and leading data management, monitoring and statistical analysis
- Owning technical transfers and process validation
- Defining and maintaining the product control strategy
- Owning comparability and product characterization
- Identifying commercial process/product life cycle improvements
- Identifying and driving implementation of improvements to maximize throughput and capacity utilization
Within the Vitry-sur-Seine local Manufacturing Sciences And Technology (MSAT) organization, we are looking for an experienced Downstream Process Engineer to join our expanding team.
- Manages process fit-gap assessment in tech transfer team for purification, formulation and filling processes and identify areas requiring mitigation via process adaptation or facility modification
- Leads process validation including strategy definition, the execution follow-up and documentation management
- Defines and maintains the process control strategy for DSP
- Routinely monitors DSP manufacturing process and identify trends and resolves using her/his expertise and site resources, where possible, or escalate to MSAT governing body requiring additional expertise and resources
- Leads DSP process related complex problem investigation at the site by using solid process understanding and use of scientific and engineering principles and practices and facilitates generation of practical solutions
- As a downstream processing SME, provides technical support during health authority inspection
- Drives continuous process robustness and improvement in order to make processes more cost effective at the same time maintaining quality and HSE requirements
- Develops connection within global MSAT in international context
- Master’s Degree or PhD in engineering or science with minimum 5 years of experience in cGMP manufacturing environment or biologics process development
- Strong experience in process development, process characterization, technology transfer and process validation in bio-manufacture industry
- Knowledge of purification technologies and operations
- Knowledge of viral clearance of purification processes
- Experience with automated protein purification chromatography and UF/DF
- Experience with DeltaV Process Control system
- Experience in cGMP and good understanding of regulatory requirements for biologics manufacturing
- Strong knowledge in data management and statistical analysis
- Proficiency with MS Office (Excel, Power Point, Word)
- Ability to make a significant contribution to cross-functional project teams through technical expertise and scientific creativity
- Team player, ability to work effectively in a highly collaborative and dynamic environment
- Excellent communication skills
- Fluent in French and English
- Ability to travel (up to 20% of time)
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.
As part of its diversity commitment, Sanofi is welcoming and integrating people with disabilities.
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