Associate Engineer – Downstream Manufacturing (Process)

About the role

The Manufacturing team is expanding and seeks an Associate Engineer to support routine downstream biopharmaceutical manufacturing operations in Tuas, Singapore. The role focuses on ensuring process robustness and compliance with GMP requirements while executing seed train, cell culture, bioreactor, chromatography and viral inactivation steps.

Key responsibilities

• Support day‑to‑day downstream manufacturing within the assigned scope.
• Monitor critical process parameters, trends and performance indicators to keep operations within control limits.
• Identify and document process deviations, abnormalities or drift, and escalate issues promptly.
• Provide technical support to Manufacturing Operations and act as the operational SME for assigned downstream unit operations.
• Update downstream SOPs, batch records and related documentation for new or modified processes.
• Review and trend process data to pinpoint variability and drive continuous improvement.
• Collaborate with MSAT and Automation teams to leverage digital tools and process data.
• Assist with New Product Introduction, process startup, engineering runs, PPQ and validation activities as required.
• Participate in risk assessments (e.g., FMEA) and support deviation investigations and CAPA activities.

Required profile

Required skills

• Seed train operations
• Cell culture techniques
• Bioreactor operation and monitoring
• Multi‑column chromatography
• Viral inactivation processes
• GMP compliance
• Process monitoring and data analysis
• Process troubleshooting
• Process documentation and SOP maintenance