Sanofi Manufacturing and Supply organization is preparing its future through an ambitious program named EVolutiveFacility (EVF). The EVF Project is at the cornerstone of Sanofi strategy as it aims at creating a new manufacturing concept consisting of a new generation of evolutive multi-product facilities, modular, adaptableand agile, leveragingnew disruptive technologies, to better address vaccine business challenges as well as Specialty Care Biologics products. One of these two EVF is implemented in Singapore in a new Greenfield site, with a design identical to the one in Neuville (France). The facilities will also have highly digitalized and automated capabilities which is akeyenabler for operations usingtechnologies such as autonomous guided vehicles(AGVs), cobotsand cloud systems.
The Manufacturing Support team in Sanofi EVF, Singapore is seekingto expand the team and has an open position as Manufacturing Support Senior Engineer specializing in Upstream/Downstream biological processes. The successful applicant for this position will be joining the Manufacturing team locatedin Sanofi EVF, Tuas Singapore. The purpose of this role is to provide technical expertise for upstream/downstream processes areas in various activities like shopfloor support for process equipment troubleshooting activities and investigation during Manufacturing.
The role will reportto theSenior Manufacturing Support Manager, Manufacturing. In this role, you will act as SME for Upstream/Downstream to provide technical expertise during the project startup phase and as well as during the routine manufacturing.
During the project phase, theSenior Manufacturing Support Engineer, Manufacturingwillprovide technical support during project startup phase with respect to process equipment, commissioning qualification and validation (CQV) activities and defining DeltaVand MES workflows.
Beyond the project phase, the Senior Manufacturing Support Engineer, will have aroutine manufacturingsupportrolenot limited to the following:
- Identifythe root cause of technical problems and effectively resolve these to ensure process and equipment availabilityas Deviation/CAPA/Change Control owner
- Ensure a responsive and effective resolution of complex problems that are interdisciplinary in nature
- Assist the Manufacturing Operations team in providing technical expertisefor the troubleshooting of equipment breakdown and failures
- Lead cross-functional team in identifyingareas of improvement and implementing continuous improvements to enhance reliability and cost-effectiveness
- Lead/participateas SME in process risk/gap assessments, investigations, deviations, change controls and CAPA implementation in support of manufacturing operations.
Pre-requisites
Knowledge, Skills & Competencies / Language
Self-starter and independent worker who canoperateand perform in cross functional teams.
Possess analytical and critical thinking skillswith the ability to problem solve and navigate through complexity and ambiguity.
Able to work in fast paced and dynamic conditions with tighttimelines.
Excellent analytical, consultative, and diagnostic skills with ability to make sound, data-based business decisions.
Effective communication skills necessary to interact with internal stakeholders (includes strong presentation skills).
Goodtechnical writing skills.
Team player.
Qualifications / Requirement
Bachelor’s Degree in arelated Engineeringor Science discipline.
>8years of relevant working experiencein the cGMP biopharmaceutical facility.
Previouswork experience with mammalian cell culture would be desirable and experience with continuous manufacturing such as continuous chromatography would be an advantage.
Familiarity and prior working experience with Single Use Systems would be preferred.
Experience working with Digital systems, e.g. DeltaV, MES, would be preferred.
Experience in change management, stakeholder management, process innovation and optimization, equipment troubleshooting.
Any other requirements of the job
Working hours during the initialProject Phase-work office hours (weekdays) at Sanofi Tuas Site Office.
Working hours beyond the Project Phase -work office hours (weekdays) on site to support production activities.
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