Job title: Senior Engineer I (Manufacturing Support)
Location: Singapore
Hiring Manager: Senior Manager, Manufacturing Support
About the job:
We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.
Sanofi has added two new Evolutive Facilities to our global industrial footprint. These production units (EVF) represent the future of manufacturing. They allow us to increase our capacities while making production more flexible and respectful of the environment.
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Fully digitalized, our Evolutive Facilities (EVF) will enable more responsive and flexible manufacturing across multiple vaccine and biological platforms including mRNA, while minimize our impact to the environment. Our EVFs will help improve people's lives by giving them faster access to more treatments.
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.
Main responsibilities
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.
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.