Upstream Process Engineer / Upstream Manufacturing Process Specialist M/F
date posted 08/19/2020
contract typeFull time
job id R2562933
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 modeling, 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 Upstream Process Engineer to join our expanding team.
Manages process fit-gap assessment in tech transfer team for upstream and identify areas requiring mitigation via process adaptation or facility modification
Leads process validation including strategy definition, documentation management and execution follow-up
Defines and maintains the process control strategy for USP
Routinely monitors USP 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 USP 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 an upstream 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
Experience in Mammalian cell culture including seed train, large scale bioreactors and cell culture clarification
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
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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