Associate Engineer – Downstream Manufacturing (Process)

About the role

The Manufacturing team in Tuas, Singapore is looking for an Associate Engineer to support routine downstream biopharmaceutical manufacturing operations. The role focuses on ensuring process robustness and compliance with GMP requirements across downstream unit operations.

Key responsibilities

• Support day‑to‑day downstream manufacturing within the assigned scope, monitoring critical process parameters and trends.
• Identify and document process deviations, abnormalities, or drift, and escalate issues promptly.
• Provide technical support to Manufacturing Operations and act as the subject‑matter expert for assigned downstream unit operations.
• Maintain and update downstream SOPs, batch records, and related documentation.
• Review and trend process data to identify variability and opportunities for improvement.
• Collaborate with MSAT and Automation teams to leverage digital tools and process data.
• Assist with New Product Introduction (NPI) and startup activities, including engineering runs, PPQ, data collection, and risk assessments.
• Participate in deviation investigations and CAPA activities.

Required profile

• Relevant engineering or life‑science background.
• Understanding of GMP requirements in a biopharmaceutical environment.
• Ability to work collaboratively with cross‑functional teams.

Required skills

• Seed train and cell culture operations
• Bioreactor operation
• Multi‑column chromatography
• Viral inactivation processes
• Process monitoring and data analysis
• GMP compliance
• Documentation of SOPs and batch records