MSAT Engineer

Company

A global organization operating in advanced biopharmaceutical manufacturing, focused on innovative therapies and strict quality and compliance standards. The company supports cutting‑edge production processes in highly regulated environments to deliver life‑changing treatments.

This role focuses on supporting manufacturing operations within the Manufacturing Science and Technology function. The position plays a key role in ensuring smooth commercial production of cell‑based therapies while maintaining compliance with regulatory requirements. You will be involved in process investigations, product release support, and continuous improvement initiatives while working closely with cross‑functional teams.

• Perform impact assessments to support product release activities
• Lead and support deviation investigations using root cause analysis methodologies
• Develop and manage corrective and preventive actions
• Collaborate with manufacturing, quality, and technical teams to resolve issues
• Author and review SOPs, batch records, and GMP documentation
• Support change control processes and process improvements
• Contribute to manufacturing projects and operational excellence
• Ensure compliance with regulatory standards and internal quality systems

• Bachelor’s degree in biochemical engineering, chemical engineering, biotechnology, or related field
• Engineering background preferred
• Experience with cell culture, cell therapy, or aseptic manufacturing
• Strong knowledge of GMP and pharmaceutical manufacturing standards
• Hands‑on experience with deviation investigations, root cause analysis, CAPA, and change control
• Experience in technical documentation and report writing
• Strong understanding of biopharmaceutical manufacturing processes
• Excellent communication and collaboration skills

Department:
Manufacturing Science and Technology

Function:
Manufacturing Operations and Compliance Support

Work environment: GMP regulated production setting