Job Description

Mission

Vaccines Industrial Affaires (VIA) is preparing its future through an ambitious program named Evolutive Vaccine Facility (EVF). The EVF Project is the cornerstone of Sanofi\'s strategy as it aims to create a new manufacturing concept consisting of a new generation of evolutive multi-product facilities, modular, adaptable, and agile, leveraging new disruptive technologies, to better address the challenges of the vaccine business.

Within the Evolutive Vaccine Facility (EVF) project, the EVF Operation Support Engineer participates in all activities from design phase when he/she will closely work with Manufacturing Technology (M-Tech), Quality Assurance (QA) team and the Engineering & Technical Services (ETS) teams implement a lean, flexible and efficient asset focusing on the agility and easiness to manufacture any product needed from Phase 2 and/or 3 Clinical Material to routine Commercial production.

Key Accountabilities

Reporting to Operations Quality Assistance Leader during the project phase, key accountabilities of the role are listed below:

• 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 Support Engineer:
  • Subject matter expert (SME) for process equipment performance and operation to ensure safety, compliance and sustained operation.
  • Lead and participate in equipment investigations to identify root causes and effectively communicate to the stakeholders on the plans and mitigating actions.
  • Ensure operation continuity through asset lifecycle management planning, assess and identify impact to safety, compliance, operational schedule and cost.
  • Perform assessment for equipment during new product introduction, change controls and other qualifications activities to ensure equipment are in its validated state.
  • Collaborate with Manufacturing 4.0 Integrated Manufacturing Solutions team to implement digital tools for training.
  • Actively seek opportunities for continuous improvement through use of new technologies and best industry practices.
  • Responsible for commissioning and qualification activities including FAT, SAT, automation checkouts, IQ, OQ, PQ, and asset/preventive maintenance/spare parts creation for new process equipment
  • Participate in the system walk-down, ensure the closure of punch items and support the takeover of the system from the project team

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\xe2\x80\x99s driver

Skills And Knowledge Expected

• 
  Good shopfloor and operational knowledge of Biopharmaceutical processes (fermentation / cell culture / centrifugation / chromatography / precipitation / TFF \xe2\x80\x93 pathogenic live agents) and single-use technologies
• Good communication skills and a team player
• Good knowledge of commissioning and qualification activities in a startup environment
• Knowledge in instructional design and change management concepts
• Proven ability to work as part of an integrated, networked team, and collaborate across functional, organizational, and location boundaries and be people-first values driven
• Excellent analytical, consultative, and diagnostic skills with ability to make sound, data-based business decisions
• Engaging, dynamic
• Adaptable, relationship focused
• Self-organized
• Proactive, Result-oriented

Education And Experience

• Experiences in biotech manufacturing or process engineering
• Demonstrated experience in driving innovation and change to improve efficiencies
• Bachelor\xe2\x80\x99s degree in Engineering, with at least 5 years of related experience
• Fluent in English (writing and speaking)

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.

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.