Summary

Responsible for execution of maintenance & calibration activities and commissioning activities for projects in RLT CN Project. Ensure technical indepth understanding on process machine and Radiation related QC machine to ensure the capability of problem solving and supporting on routine operations. Might provide on-shift support to ensure a reliable machine performance for technical transfer and future site operations.

About the Role

Strategy & Organizational Development

• Support internal and external audits

Maintenance & Calibration

• Prepare tools, spare parts etc. for maintenance / calibration
• Identify spare parts for maintenance and maintain pick-lists
• Get permits for maintenance / calibration / projects
• Execute work orders for maintenance / calibration as per method statement / procedure
• Supervise maintenance / calibration work as Subject Matter Expert (SME)
• Update CMMS after maintenance / calibration completion
• Document execution of calibration
• Manage stores for spare parts (good receipt, incoming inspection, delivery to work area, make parts for quick repairs and improvements)

Project Engineering & Control

• On shifts support to ensure a reliable machine performance for technical transfer and future site operations.
• Prepare, review and approve drawings, lists, schedules, diagrams, layouts, calculations and datasheets in project
• Collaborate with project vendors / contractors / 3rd parties in project
• Perform or support commissioning & qualification in projects
• Collaborate with Lean Digital, IT and OT systems into routine machine operations. Support routine problem solving when joint issue identified from IT/OT and machine setup.
• Perform new equipment FAT / SAT / inspections in project
• Perform commission activities
• Conduct problem solving for project deficiencies or deviations.

(Re-) Qualification

• Perform GMP risk assessments (incl. Sensors SRA)
• Create DQ, IQ and OQ protocols
• Execute DQ, IQ and OQ
• Create DQ, IQ and OQ reports
• Provide technical trouble shooting during PQ and validation

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Division
Operations

Business Unit
Innovative Medicines

Location
China

Site
Haiyan (Zhejiang Province)

Company / Legal Entity
CN27 (FCRS = CN027) Novartis Pharmaceutical Technology Zhejiang Co., Ltd.

Functional Area
Technical Operations

Job Type
Full time

Employment Type
Regular

Shift Work
No