Job Description

Mission
Within the Evolutive Vaccine Facility (EVF) project, the EVF Process Manufacturing Coordinator (Process Engineering) participates in all activities from design phase when he/she will closely work with Manufacturing Technology (M-Tech), Quality Assurance team and the Engineering & Technical Services (ETS) teams in the design and implementation of the EVF operations strategy in routine manufacturing including the aspects of safety, compliance, business process improvements and operational activities.
The candidate should leverage new developments and novel approach in the field of process (upstream and downstream) where he/she will contribute to design and implement a lean, flexible and efficient operations flow focusing on the agility to manufacture any product needed from Phase 2 and/or 3 Clinical Material to routine Commercial production on production shopfloor.
Key accountabilities
Reporting to Process Manufacturing Leader, with dotted line reporting to Process Engineering Leader during the project phase, key accountabilities of the role are listed below:
Project phase:
Project management
Manage transversal project teams and vendors (different equipment packages)
Drive project execution from detailed engineering down to performance qualification
Ensure compliance to applicable HSE and quality guidelines
Process engineering
Responsible for the design, construction, qualification of process equipment
Create URS for process systems, and prepare/review technical documents
Design and lead engineering studies with selected external partners
Ensure full technical project execution for process equipment (from sourcing, equipment technical evaluation and vendor selection, design, construction, CQ, to commercial start-up)
Supports facility design flow, risk assessments and other related items.
Commissioning and Qualification
Drive the commissioning and qualification effort of the process equipment and associated systems
Draft C&Q protocols
Develop/review C&Q deliverables including risk assessments, system impact assessments, requirement traceability matrix, validation plans, protocols and reports etc. that support the qualification and validation of process equipment
Perform commissioning and qualification activities of process equipment
Ensure GMP and operational readiness of the equipment
To acquire strong process manufacturing and equipment knowledge from donor site, M-Tech and ETS teams.
Routine manufacturing phase as Operations Supervisor:
To drive and act on production shopfloor to ensure the team meets the required manufacturing KPIs (Safety, Quality, Cost, Supply and People).
Develop his/her team
Set individual objectives that are realistic, ambitious, consistent with EVF strategy and measurable
Ensure her/his teams has a clear vision of their strengths and their development areas.
Immediate feedback / escalation to any member of staffs if any action that does not comply with GMP or HSE rules is observed.
Ensure that the team manufacture the product in strict compliance to safety, quality and process requirements.
Analyze and propose continuous improvement actions based on the data in performance dashboards or routine shopfloor observations.
Maintain excellent cross shift communication and action follow up.
Scope and dimensions
Breadth of responsibility (global and site):
Scope is local, focus primarily on activities in Sanofi Tuas site, with some transversal engagement with product donor site as well as Neuville EVF site.
Impact on defining, designing, and implementing the best process engineering design for routine agile manufacturing approach.
Various interactions specifically with M-Tech and ETS teams and beyond with all project functions involved in the process approach definition (HSE, Quality, Digital, Supply chain) as well as with external contractors and suppliers.
Key dimensions:
Develops and demonstrates innovation skills in project and production environment / Think out of the box
Eager to work with fully digital tools: Manufacturing control system / MES / PCS / Smart devices / paperless systems
Ability to work in multi-disciplinary and multicultural team / Excellent communication ability / Team spirit
Independent
Manufacturing KPI's driver
Education and experience
Bachelor's degree with > 5 years of biotech manufacturing or process engineering
Good shopfloor and operational knowledge of Upstream and/or Downstream Manufacturing activities (fermentation / cell culture / centrifugation / chromatography / precipitation / TFF - pathogenic live agents)
Good knowledge of commissioning and qualification activities in a start up environment
Good knowledge and eager to work with fully digital systems (PCS, MES, SAP and other software)
Good knowledge of GMP manufacturing environment, concepts, and requirements
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.