Manufacturing Engineer – Cleaning

About the role

The Manufacturing Engineer – Cleaning will work closely with cross‑functional teams, especially Sterility Assurance, to develop and maintain cleaning processes for all product groups at the Suzhou site. The role ensures compliant start‑up of manufacturing, supports SAP process routing, and drives continuous improvement in quality, cost, and efficiency.

Key responsibilities

• Develop and maintain packaging, labeling, and cleaning processes in collaboration with Sterility Assurance and other departments.
• Coordinate with China and overseas functions to ensure timely, compliant manufacturing start‑up at the Suzhou facility.
• Maintain SAP process routing to guarantee compliance with procedures and validation results.
• Compile manufacturing procedures related to cleaning processes and deliver training to shop‑floor employees.
• Partner with maintenance and calibration teams to implement maintenance programs and calibration activities.
• Lead or participate in continuous‑improvement projects using risk‑assessment summaries, statistical techniques, and other methodologies.
• Support capacity planning, equipment layout design, machine qualification, and process validation.
• Collaborate with Quality to develop and implement the quality system and manage non‑conformance data and product traceability.

Required profile

• Strong knowledge of FDA QSR, ISO 9000, and CFDA quality requirements.
• Experience with SAP for process routing and documentation control.
• Financial awareness to identify capital spend and budgeting needs.
• Ability to work onsite in Suzhou and coordinate with international teams.

Required skills

• SAP process management
• Process validation and equipment qualification
• Statistical analysis and risk‑assessment techniques
• Maintenance program development and calibration
• Training delivery for manufacturing staff