Production Support Operator (Materials, Cleaning, Sterilization)
roche · Shanghai
Job description
About the role
Roche is hiring a production support operator in Shanghai for its manufacturing site. The role covers materials, cleaning and sterilization, and also supports engineering projects, equipment qualification, process validation and GMP-compliant routine operations.
Key responsibilities
- Clean the facility and prepare cleanroom garments.
- Operate, manipulate and clean cleaning and sterilization equipment, and diagnose and resolve equipment faults with maintenance engineers to minimise downtime.
- Support equipment qualification and process validation, including autoclave requalification.
- Support documentation revision and writing of deviations, CAPA and planned events.
- Take part in new facility design and construction, including process design, FAT, SAT, IOPQ, CHT and SHT, and help develop and optimise logistics processes.
- Help set up operation readiness: draft equipment operation procedures and logbooks, 5S and machine cleaning according to the readiness plan.
- Perform routine operations in line with Roche's GMP/SHE and regulatory requirements, keeping data accurate, intact and traceable.
- Handle related IT systems such as SAP, MES, Veeva and Cornerstone.
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roche
Shanghai