Manufacturing Process Engineer

Job Description :

We are seeking a Manufacturing Process Engineer to join the Manufacturing Science and Technology (MS&T) team, supporting late-stage manufacturing and PPQ readiness for an autologous cell therapy product. This role requires a strong background in GMP operations, process control strategy implementation, risk assessment, and manufacturing support. The engineer will serve as a subject matter expert (SME) driving technical excellence, ensuring process robustness, and supporting regulatory compliance in a cross-functional environment.

Responsibilities :

• Implement and support late-stage manufacturing process control strategies for cell therapy drug product.
• nalyse and monitor process performance data to ensure process consistency and readiness for PPQ.
• Collaborate with process development and manufacturing teams to support tech transfer activities and execution of late-stage PD deliverables.
• Participate in the preparation and execution of ancillary PPQ protocols (e.g., buffer stability, intermediate hold times) and summary reports.
• Contribute to risk assessments, including Extractables & Leachable (E&L), and consumables qualification.
• Support the selection and justification of single-use systems and sterile processing equipment.
• Review and interpret SOPs and execute work instructions related to manufacturing readiness and qualification efforts.
• ct as an MS&T representative in cross-functional investigations, leading or supporting root cause analysis and proposing data-driven corrective actions.
• Ensure alignment with cGMP, FDA, ICH, and internal quality standards throughout all activities.
• Engage proactively with cross-functional stakeholders to ensure manufacturing processes meet regulatory and operational expectations.

Requirements :