Job Description

Job title: Senior Engineer I, Manufacturing (NPI) (Modulus Singapore)Location: SingaporeHiring Manager: Senior Manager, Manufacturing SupportAbout the job:Sanofi Manufacturing and Supply organization is preparing its future through an ambitious program named EVolutive Facility (EVF) and soon to be rebranded to Modulus. 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, adaptable and agile, leveraging new 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 a key enabler for operations using technologies such as autonomous guided vehicles (AGVs), cobots and cloud systems.The New Product Introduction (NPI) team in Sanofi EVF, Singapore is seeking to expand the team and has an open position as NPI Senior Engineer specializing in technology transfer of new product/biological processes. The successful applicant for this position will be joining the Manufacturing team located in Sanofi EVF, Tuas Singapore.The role will report to the Senior Manufacturing NPI, Manufacturing. In this role, you will be responsible to provide technical expertise for technology transfer of the new product and support the design, commissioning and qualification of the new Manufacturing Facility and Equipment.Main responsibilities:The Senior Manufacturing Support Engineer, will (not limited to the following):Collaborate closely with MSAT, Process Engineering, Automation, Quality Control (QC), Quality Assurance (QA), Supply Chain (SC), Manufacturing Operations, Digital and Health, Safety and Environment (HSE) to ensure successful completion of NPI transfer (examples):\xc2\xb7 Partner with MSAT to coordinate successful transfer operations and to ensure the successful integration of process knowledge into manufacturing operations\xc2\xb7 Partner with SC to support development of Bill of Material (BoM) and demand planning for new products\xc2\xb7 Partner with Process Engineering, Automation, Digital etc to conduct Facility fit assessments and plans to support system updates needed for new product introduction\xc2\xb7 Partner with Manufacturing Operations and QA to develop electronic batch records, robust processes and innovative technology solutions for new product introduction\xc2\xb7 Partner with Quality, CQV and MSAT to develop and implement process Validation and Comparability study activities leading to successful product registrationEnsure a responsive and effective resolution of complex problems that are interdisciplinary in nature Assist the Manufacturing Operations team in providing technical expertise for investigations and troubleshooting of equipment breakdown and failures related to NPI activities.Lead cross-functional team in identifying areas of improvement and implementing continuous improvements to enhance reliability and cost-effectiveness in NPI activities Lead/participate as SME in process risk/gap assessments, investigations, deviations, change controls and CAPA implementation in support of NPI activitiesAs the Subject Matter Expert (SME) to support the team for regulatory inspection audits related to NPIAbout You:Knowledge, Skills & Competencies / Language\xc2\xb7 Self-starter and independent worker who can operate and perform in cross functional teams.\xc2\xb7 Possess analytical and critical thinking skills with the ability to problem solve and navigate through complexity and ambiguity.\xc2\xb7 Able to work in fast paced and dynamic conditions with tight timelines.\xc2\xb7 Excellent analytical, consultative, and diagnostic skills with ability to make sound, data-based business decisions.\xc2\xb7 Effective communication skills necessary to interact with internal stakeholders (includes strong presentation skills).\xc2\xb7 Good technical writing skills.\xc2\xb7 Team player.Qualifications / Requirement\xc2\xb7 Bachelor\xe2\x80\x99s Degree in a related Engineering or Science discipline.\xc2\xb7
8 years of relevant working experience in the cGMP biopharmaceutical facility.\xc2\xb7 Previous work experience with mammalian cell culture would be desirable and experience with continuous manufacturing such as continuous chromatography would be an advantage.\xc2\xb7 Familiarity and prior working experience with Single Use Systems would be preferred.\xc2\xb7 Experience working with Digital systems, e.g. DeltaV, MES, would be preferred.\xc2\xb7 Experience in change management, stakeholder management, process innovation and optimization, equipment troubleshooting.Any other requirements of the job\xc2\xb7 Working hours during the initial Project Phase \xe2\x80\x93 work office hours (weekdays) at Sanofi Tuas Site Office.\xc2\xb7 Working hours beyond the Project Phase \xe2\x80\x93 work office hours (weekdays) on site to support production activities.Pursue progress, discover extraordinaryBetter is out there. Better medications, better outcomes, better science. But progress doesn\xe2\x80\x99t happen without people \xe2\x80\x93 people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let\xe2\x80\x99s be those people.At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.Watch our and check out our Diversity Equity and Inclusion actions at !

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