Senior Engineer I

Sanofi; Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

Sanofi Manufacturing and Supply Organization in Singapore seeks a Senior Manufacturing Support Engineer specializing in Upstream/Downstream bioprocesses to provide SME technical expertise for startup and routine operations.

You will lead cross-functional investigations, deviations, CAPA and change controls, support CQV activities, and drive continuous improvements to enhance reliability and cost-effectiveness on the Tuas site.

Qualifications

• Bachelor's degree in engineering or science.
• 8+ years of relevant working experience in cGMP biopharmaceutical facilities.
• Experience with mammalian cell culture and continuous manufacturing is advantageous.
• Familiarity with DeltaV and MES is preferred.

Responsibilities

• Provide SME technical expertise for upstream/downstream processes on shop floor and during startup.
• Lead investigations, deviations, CAPA, and change controls.
• Support CQV activities and define DeltaV/MES workflows for manufacturing operations.
• Drive continuous improvements to enhance reliability and cost-effectiveness.

Skills

Upstream processes

Downstream processes

CQV/Qualification

DeltaV

MES

Root cause analysis

Continuous improvement

Digital systems

Education

Bachelor's Degree in Engineering or Science

Tools

DeltaV

MES

Single Use Systems

Job description

Sanofi Manufacturing and Supply Organization is preparing its future through an ambitious program named EVolutive Facility (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, 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 Manufacturing Support team in Sanofi EVF, Singapore is seeking to 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 located in 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 report to the Senior 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, the Senior Manufacturing Support Engineer, Manufacturing will provide technical support during project startup phase with respect to process equipment, commissioning qualification and validation (CQV) activities and defining DeltaV and MES workflows.

Beyond the project phase, the Senior Manufacturing Support Engineer, will have a routine manufacturing support role not limited to the following:

• Identify the root cause of technical problems and effectively resolve these to ensure process and equipment availability as 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 expertise for the 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 in support of manufacturing operations.

Pre-requisites

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.