Associate Engineer

Sanofi Aventis Singapore Pte. Ltd; Singapore; On-site; SGD 56,000 - 89,000; Full time

Job summary

Sanofi is seeking an Associate Engineer, Manufacturing – Downstream (Process) in Tuas, Singapore. The role supports routine downstream biopharmaceutical manufacturing operations with focus on process robustness and compliance.

You will monitor process performance, analyze trends, and contribute to continuous improvement of downstream robustness, while supporting NPI, startup, and validation activities when needed.

Qualifications

• Basic understanding of downstream biopharmaceutical processes.
• Working knowledge of GMP requirements and data integrity principles.
• Basic data analysis and trending capability.
• Ability to work effectively in cross‑functional teams.
• Structured problem solving and analytical thinking.
• Good technical writing and communication skills.

Responsibilities

• Support routine downstream manufacturing operations within assigned scope.
• Monitor critical process parameters and performance indicators to stay within control limits.
• Identify deviations and escalate issues promptly.
• Provide day‑to‑day technical support to Manufacturing Operations for downstream processes.
• Serve as operational SME for assigned downstream unit operations, ensuring safe and compliant performance.
• Assist updates to SOPs, batch records, and process documentation.

Skills

Downstream processes

GMP knowledge

Data analysis

Cross-functional teamwork

Problem solving

Technical writing

Team player

Education

Biotech/Engineering degree

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. 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. 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. 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. Deviation, Investigation & CAPA Support

• Participate in process related deviations and investigations

• Escalate complex issues to Senior Engineers in a timely manner.

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. 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

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