Senior Specialist - Filling (Aseptic Filling)

About the role

Roche is hiring a (Senior) Specialist - Filling in Shanghai, within its Engineering Project Support and Operation Readiness function. The role covers the design and construction of new facilities, the development of aseptic filling processes, and routine operation of the filling line in compliance with GMP and SHE requirements.

Key responsibilities

• Take part in new facility design and construction, including process design, FAT, SAT, IOPQ, smoke study, VHP, Isolator EMPQ, APS and similar activities.
• Help develop and optimise aseptic filling processes and support operation readiness, such as drafting equipment operation procedures and logs, 5S and machine cleaning plans.
• Perform routine operations such as vial washing, filling and stoppering, capping, and train new employees.
• Support environmental monitoring of the isolator environment, handle production deviations and implement CAPA, and resolve equipment faults quickly with maintenance engineers.
• Carry out regular validation activities such as APS, ensure data accuracy and traceability in the GMP area, and run related IT systems such as SAP, MES, Veeva and Cornerstone.

Required profile

• College degree (Pharmaceutical or Biological preferred) and above.
• 5+ years of operation experience in the injection pharmaceutical industry; MNC biopharma experience preferred.
• Experience with aseptic filling facility projects, including design, commissioning and qualification; Isolator filling line experience preferred.
• Strong knowledge of cGMP and pharmaceutical regulations, especially in the biological industry.
• Fluent English communication skills preferred.