Associate Engineer, Manufacturing – Upstream (Process)

Role overview

Sanofi’s manufacturing organization is looking to add an Associate Engineer focused on upstream process support. The role is centered on keeping routine biopharmaceutical manufacturing activities stable, compliant, and process-robust across defined upstream operations.

This position supports day-to-day execution in upstream manufacturing, making sure activities such as seed train work, cell culture, bioreactor operation, multi-column chromatography, and viral inactivation are carried out consistently and within approved process settings, while meeting GMP expectations.

Working within a clearly defined scope, the Associate Engineer helps Manufacturing Operations by tracking process performance, reviewing trends, assisting with investigations, and contributing to improvements that strengthen process robustness. Where needed, the role also provides support for New Product Introduction (NPI), process start-up, and validation work, mainly through execution support, monitoring, and documentation.

The position reports to the Senior Manager, Manufacturing and works with several cross-functional teams.

Responsibilities

• Support routine upstream manufacturing activities within the assigned area of responsibility.
• Track critical process parameters, trends, and performance indicators to confirm the process stays within defined control limits.
• Spot process drift, deviations, or unusual behavior, record findings, and escalate concerns promptly.
• Provide practical technical support to Manufacturing Operations for upstream process execution.
• Serve as the operational subject matter resource for assigned upstream unit operations, helping maintain safe, compliant, and reliable performance.
• Assist with revisions to upstream SOPs, batch records, and related process documentation for new or changed processes.
• Review and trend upstream process data to identify variability, repeated issues, and improvement opportunities.
• Support process changes aimed at improving robustness, yield, consistency, and operational reliability.
• Work with MSAT and Automation teams to support the use of digital tools and process data.
• Assist with NPI and process start-up activities when assigned, including engineering runs, PPQ, startup manufacturing, data collection, verification, and documentation.
• Support readiness checks and operational handover tasks for new or modified processes.
• Contribute information for upstream risk assessments such as FMEA and help track resulting actions.
• Participate in process-related deviations and investigations.
• Escalate complex problems to Senior Engineers without delay.
• Carry out assigned work in line with GMP, EHS, and site requirements.
• Help maintain audit and inspection readiness through accurate, timely records.
• Identify opportunities to improve upstream process control, robustness, or execution.
• Take part in OE, Lean, and other continuous improvement initiatives related to upstream manufacturing.

Requirements

• Basic knowledge of upstream biopharmaceutical processes, including seed train, cell culture, bioreactor operations, multi-column chromatography, and viral inactivation.
• Working understanding of GMP requirements and data integrity principles.
• Ability to perform basic data review and trending to support process monitoring.
• Comfortable collaborating with cross-functional teams with appropriate supervision or guidance.
• Structured approach to problem-solving with strong analytical thinking.
• Good technical writing and communication skills.
• Team-oriented mindset and willingness to keep learning.
• Diploma or bachelor’s degree in Biotechnology, Biochemical Engineering, Chemical Engineering, Life Sciences, or a related field.
• 3 to 4 years of experience in upstream biopharmaceutical manufacturing, process support, or manufacturing operations in a regulated environment.

Additional information

This role is based in Singapore and is a full-time onsite position.

The job is tied to upstream biopharmaceutical manufacturing operations and may involve support for validation, startup, and process change activities in addition to routine production support.

All work must be performed in compliance with GMP, safety, and site standards, with an emphasis on documentation quality and inspection readiness.

Skills

Upstream bioprocessing, GMP compliance, process trending, biopharmaceutical manufacturing, technical documentation, deviation handling, investigation support, continuous improvement, analytical thinking, cross-functional collaboration, data integrity