Solution Preparation Operator (Biologics)

About the role

Roche is hiring a solution preparation operator in Shanghai for its engineering project support and operation readiness work. The role covers both the preparation of biological drug substances and the support of new facility design and commissioning.

Key responsibilities

• Take part in new facility design and construction, including process design, FAT, SAT, IOPQ and APS, and help deliver projects.
• Support the initial development and optimisation of thawing and formulation processes.
• Help implement operation readiness: draft equipment operation procedures and logs, 5S and machine cleaning according to the readiness plan.
• Perform routine operations in line with GMP/SHE and regulatory requirements, such as thawing, compounding, formulation, mixing and filtration.
• Diagnose and resolve equipment faults quickly with maintenance engineers to minimise downtime.
• Carry out regular validation activities such as APS and keep data accurate, complete and traceable in the GMP area.
• Handle related IT systems such as SAP, MES, Veeva and Cornerstone.

Required profile

• Senior high school or technical school education (pharmaceutical or biological preferred).
• Experience in the injection pharmaceutical industry; MNC biopharma preferred.
• Knowledge of factors affecting biopharmaceutical quality.
• Experience with aseptic production facilities, including design, commissioning and qualification; single-use technology preferred.
• Strong knowledge of cGMP and pharmaceutical regulations, especially for biologics.
• Basic English communication skills preferred.