Process Engineer

Company

Our client is a leading organization in the field of cellular medicine, committed to advancing innovative therapies and pushing the boundaries of healthcare through cutting‑edge manufacturing practices and continuous improvement.

We are seeking a dedicated Process Improvement Specialist to join the Manufacturing Operations and - Compliance Support team within the Manufacturing Science and Technology (MSAT) department. The successful candidate will support product release, investigate root causes of deviations, and contribute to ongoing process enhancements at a facility manufacturing T‑cell therapy products.

• Collaborate with technical and operational teams to create, review, and update standard operating procedures (SOPs), batch records, and other operational documents.
• Lead investigations into deviations, applying root cause analysis tools to identify underlying issues.
• Develop and implement corrective and preventive actions (CAPAs) to resolve root causes and ensure long‑term effectiveness.
• Support continuous improvement initiatives to optimize manufacturing processes.
• Assist with impact assessments related to product release and participate in validation activities.
• Perform additional tasks as assigned by management, supporting overall manufacturing excellence.

• Bachelor’s degree in Biochemical Engineering, Chemical Engineering, Biotechnology, or a related field; engineering degrees are advantageous.
• Relevant experience in cell culture, cell therapy, or aseptic processing.
• Strong knowledge of cGMP compliance, with experience in investigating deviations, writing reports, and managing change controls.
• Excellent communication skills and ability to collaborate effectively across cross‑functional teams.
• Practical understanding of scientific and engineering principles.
• Ability to adapt quickly in a fast‑paced, growing environment and work independently.
• Self‑motivated, detail‑oriented, with strong troubleshooting skills.

If you are interested and want to apply, please submit your application via the apply button below and contact me.