Production Process Engineer - Highly Potent Oral Solid Dosage

About the role

Roche is hiring a Production Process Engineer in Shanghai for its highly potent oral solid dosage (OSD) workshop (SHiP II). The role covers production coordination, troubleshooting, quality compliance, documentation, process validation support, equipment operation and maintenance, continuous improvement, training and EHS management.

Key responsibilities

• Coordinate daily production in the OSD workshop, allocate labour and equipment, and run shifts while ensuring strict cGMP and SOP compliance
• Troubleshoot equipment and process issues quickly, anticipate risks and support management decisions
• Lead change and deviation management, CAPA tracking and preparation for internal and external quality audits
• Draft, revise and manage SOPs and technical documents, and operate SAP, MES, Veeva and Cornerstone
• Complete and review batch records and logs, ensuring data integrity
• Support process validation, cleaning validation and equipment qualification with the MSAT team
• Operate, clean and maintain OSD and packaging line equipment, and support installation and commissioning
• Promote Lean Production and Kaizen to improve OEE and control costs
• Train new hires and frontline staff, create courses and update training plans and job descriptions
• Act as the SHE SPOC for production and packaging, covering safety assessments, STARI tracking and pest control