Senior Engineer I

The role will report to theSenior 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, theSenior 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 rolenot 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 canoperate 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 tighttimelines.

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.

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

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