Engineer II, Manufacturing

Job title: Engineer II, Manufacturing

• Hiring Manager: Senior Manager, Manufacturing (NPI)

• Location:  Tuas, Singapore

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About the job

Sanofi Manufacturing and Supply organization is preparing its future through an ambitious program named Modulus. The Modulus 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 Modulus 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.

Strategic context:

The Manufacturing team in Sanofi Modulus, Singapore is seeking to expand the team and has an open position as Engineer II, Manufacturing specializing in technology transfer and startup of a new product/biologics process line.

The role will report to the Senior Manager, Manufacturing. In this role, you will be responsible to provide user expertise for technology transfer of the new product and support the design, commissioning and qualification of the new manufacturing facility and equipment. Subsequently, this role will transition to support routine manufacturing operations as the Manufacturing Subject Matter Expert (SME).

Main responsibilities:

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 New Product Introduction (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, automation recipes, 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. Lead cross-functional team in identifying areas of improvement and implementing continuous improvements to enhance reliability and cost-effectiveness. Lead/participate as SME in process risk/gap assessments, investigations, deviations, change controls and CAPA implementation. As the Subject Matter Expert (SME) to support the team for regulatory inspection audits

Project Management

• Manage transversal project teams

• Drive project execution from detailed engineering down to performance qualification

• Ensure compliance to applicable HSE and quality guidelines

Operational and Digital Readiness, Validation and Technology Transfer

• Authoring and reviewing of operational documents (e.g. work instructions, SOPs, training documents etc.) for NPI process equipment and workflows.

• Authoring and reviewing of risk assessments and validation documents (e.g. protocol, reports etc.) for NPI process equipment/ systems.

• Provide technical and troubleshooting support during Engineering and Process Performance Qualification (PPQ)

• • Subject matter expert (SME) for process equipment performance and operation to ensure safety, compliance and sustained operation.

  • Lead and participate in investigations to identify root causes and effectively communicate to the stakeholders on the plans and mitigating actions.

About you

Main requirements:

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

• Minimum 3 years of relevant working experience in a cGMP biopharmaceutical facility.

• Previous work experience in biologics manufacturing would be preferred.

• Previous work experience in supporting plant startup would be preferred.

• Previous work experience in a digitalized and automated facility operated by DeltaV and MES would be preferred.

• Familiarity and prior working experience with Single Use Systems would be preferred.

• Experience in change management, stakeholder management, process innovation and optimization, equipment troubleshooting.

Professional skills that make the difference:

• 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.

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including health insurance, out-patient benefits along with a range of family friendly policies such as maternity, paternity, and solo parent leaves to name a few.