Associate Engineer

Sanofi; Singapore; On-site; SGD 60,000 - 85,000; Full time

Job summary

Sanofi Tuas site is seeking an Associate Engineer, Manufacturing – Downstream (Process) to support routine downstream biopharmaceutical operations with emphasis on process robustness. The role covers monitoring, deviation handling, and continuous improvement within GMP‑driven workflows.

You will collaborate with MSAT, Operations, and Quality to maintain product and process performance, participate in NPI/startup activities, and ensure accurate documentation and readiness for audits.

Qualifications

• Diploma or Bachelor’s degree in Biotechnology, Biochemical Engineering, Chemical Engineering, Life Sciences, or related discipline.
• 3–4 years of experience in downstream biopharmaceutical manufacturing, process support, or manufacturing operations in a regulated environment.
• 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.

Responsibilities

• Routine downstream manufacturing operations support within assigned scope.
• Monitor critical process parameters and trends to ensure operations stay within control limits.
• Identify deviations and document observations; escalate issues promptly.
• Provide day-to-day technical support to Manufacturing Operations for downstream execution.
• Act as SME for downstream unit operations, ensuring safe, compliant process performance.
• Support updates to SOPs, batch records, and process documentation.

Skills

Downstream biopharma

GMP knowledge

Data analysis

Cross-functional teamwork

Documentation skills

Education

Bachelor's/BSc in Biotechnology

Diploma in related field

Job description

Position: Associate Engineer Location: Tuas, Singapore

About the Job The Manufacturing team is expanding and seeking an Associate Engineer, Manufacturing – Downstream (Process) to support routine downstream biopharmaceutical manufacturing operations, with a focus on process robustness.

The Associate Engineer, Manufacturing – Downstream (Process) supports day‑to‑day downstream manufacturing operations by ensuring that downstream processes (e.g, seed train, cell culture, bioreactor operations, multi-column chromatography, viral inactivation) are executed consistently, within defined process parameters, and in compliance with GMP requirements.

The role operates within a defined process scope and supports Manufacturing Operations by monitoring process performance, analyzing trends, supporting investigations, and contributing to continuous improvement of downstream process robustness.

As required, the role may support New Product Introduction (NPI), process startup, and validation activities, primarily from an execution, monitoring, and documentation standpoint.

This position reports to the Senior Manager, Manufacturing and works closely with cross‑functional teams.

Key Responsibilities

1. 1. Routine Manufacturing & Asset Care Support (Primary Focus)

   Support routine downstream manufacturing operations within assigned scope.

   Monitor critical process parameters, trends, and process performance indicators to ensure operations remain within defined control limits.

   Identify process deviations, abnormalities, or drift; document observations and elevate issues in a timely manner.

   Provide day‑to‑day technical support to Manufacturing Operations related to downstream process execution.

   Act as operational process SME for assigned downstream unit operations, supporting safe, compliant, and consistent process performance.

   Support updates to downstream SOPs, batch records, and process documentation related to new or modified processes.

2. 2. Downstream Process Robustness & Performance

   Support routine review and trending of downstream process data to identify variability, recurring issues, or opportunities for improvement.

   Support implementation of process improvements aimed at enhancing robustness, yield, consistency, or operational reliability.

   Collaborate with MSAT and Automation teams to support effective use of digital tools and process data.

3. 3. Support to New Product Introduction (NPI) & Startup (Limited Scope)

   Support NPI and process startup activities as assigned, such as: Execution support during engineering runs, PPQ, or startup manufacturing.

   Process data collection, verification, and documentation.

   Support of process readiness and operational handover activities.

   Participate in downstream process risk assessments (e.g. FMEA) by gathering information and supporting action tracking.

   Support updates to downstream SOPs, batch records, and process documentation related to new or modified processes.

4. 4. Deviation, Investigation & CAPA

   Participate in process related deviations and investigations.

   Escalate complex issues to Senior Engineers in a timely manner.

5. 5. GMP, Safety & Compliance

   Perform assigned activities in compliance with GMP, EHS, and site requirements.

   Support audit and inspection readiness through accurate and timely documentation.

6. 6. Continuous Improvement

   Identify and propose improvement opportunities related to downstream process robustness, control, or execution.

   Participate in OE / Lean / continuous improvement initiatives focused on downstream manufacturing processes.

About You

Knowledge, Skills & Competencies

Basic understanding of downstream biopharmaceutical processes (e.g. seed train, cell culture, bioreactor operations, multi-column chromatography, viral inactivation).

Working knowledge of GMP requirements and process data integrity principles.

Basic data analysis and trending capability to support process performance monitoring.

Able to work effectively within cross‑functional teams with appropriate guidance.

Demonstrates structured problem‑solving and analytical thinking.

Good technical writing and communication skills.

Strong team player with a continuous learning mindset.

Qualifications / Requirement

Diploma or Bachelor’s degree in Biotechnology, Biochemical Engineering, Chemical Engineering, Life Sciences, or related discipline.

3–4 years of experience in downstream biopharmaceutical manufacturing, process support, or manufacturing operations in a regulated environment.

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.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! We are an R&D driven, AI-powered biopharma company committed to improving people’s lives and creating compelling growth. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives. We want to build a healthier, more resilient world, and turn the impossible into the possible by discovering, developing, and delivering medicines and vaccines for millions of people around the world. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi Start a career that makes a difference. Reinvention is in our DNA. It’s what drove our evolution from a small French enterprise to one of the world’s leading biopharma companies. Whether it’s using AI to shorten drug-discovery times or building trust in healthcare, you could be helping our teams make life better for patients, partners, and communities. This is where you grow your career. We open the door for you to explore new opportunities, push your limits, and connect with people who are driven by a shared purpose: we chase the miracles of science to improve people’s lives.