Downstream Biopharma Process Engineer (GMP)

Sanofi; Singapore; Presencial; SGD 60.000 - 85.000; Jornada completa

Descripción de la vacante

Sanofi in Tuas, Singapore is seeking an Associate Engineer, Manufacturing - Downstream (Process) to support routine downstream biopharmaceutical operations with emphasis on process robustness. You will monitor performance, investigate deviations, and drive improvements while maintaining compliance.

The role collaborates with cross-functional teams and may support NPI/startup activities, SOP updates, and documentation to ensure safe, compliant, and efficient downstream processing.

Formación

• 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.

Responsabilidades

• Routine Manufacturing & Asset Care Support (Primary Focus)
• 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 escape 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.
• 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
• Support to New Product Introduction (NPI) & Startup (Limited Scope)
• 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.
• Deviation, Investigation & CAPA Support
• Participate in process related deviations and investigations
• Escalate complex issues to Senior Engineers in a timely manner.
• GMP, Safety & Compliance
• Perform assigned activities in compliance with GMP, EHS, and site requirements.
• Support audit and inspection readiness through accurate and timely documentation.
• 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.

Conocimientos

Downstream biopharma processes

GMP compliance

Data analysis & trending

Cross-functional teamwork

Structured problem solving

Technical writing & communication

Continuous learning mindset

Educación

Biotech/biochemical or related degree

Descripción del empleo

Sanofi in Tuas, Singapore is seeking an Associate Engineer, Manufacturing - Downstream (Process) to support routine downstream biopharmaceutical operations with emphasis on process robustness. You will monitor performance, investigate deviations, and drive improvements while maintaining compliance.

The role collaborates with cross-functional teams and may support NPI/startup activities, SOP updates, and documentation to ensure safe, compliant, and efficient downstream processing.