Senior Engineer I, Manufacturing (NPI) (Modulus Singapore)

Job title: Senior Engineer I, Manufacturing (NPI) (Modulus Singapore)

Location: Singapore

Hiring Manager: Senior Manager, Manufacturing Support

About 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):

·Partner with MSAT to coordinate successful transfer operations and to ensure the successful integration of process knowledge into manufacturing operations

·Partner with SC to support development of Bill of Material (BoM) and demand planning for new products

·Partner with Process Engineering, Automation, Digital etc to conduct Facility fit assessments and plans to support system updates needed for new product introduction

·Partner with Manufacturing Operations and QA to develop electronic batch records, robust processes and innovative technology solutions for new product introduction

·Partner with Quality, CQV and MSAT to develop and implement process Validation and Comparability study activities leading to successful product registration

Ensure 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 activities

As the Subject Matter Expert (SME) to support the team for regulatory inspection audits related to NPI

About You:

Knowledge, Skills & Competencies / Language 

·Self-starter and independent worker who can operate and perform in cross functional teams. 

·Possess analytical and critical thinking skills with the ability to problem solve and navigate through complexity and ambiguity. 

·Able to work in fast paced and dynamic conditions with tight timelines.  

·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). 

·Good technical writing skills. 

·Team player.

Qualifications / Requirement 

·Bachelor’s Degree in a related Engineering or Science discipline.  

·>8 years of relevant working experience in the cGMP biopharmaceutical facility. 

·Previous work 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 initial Project 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.