Summary

Responsible for execution of Utility related maintenance & calibration activities and commissioning activities for projects in RLT CN Project. Ensure technical in depth understanding on site utility and facility to ensure the capability of problem solving and supporting on routine operations. Might provide on-shift support to ensure a reliable utility performance to support non-stop GMP environment and routine RLT products production.

About the Role

Strategy & Organizational Development

• Support internal and external audits

Maintenance & Calibration on Utilities and other Technical Supporting Facilities

• 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

• Might provide on shifts support to ensure a reliable machine performance for technical transfer and future site operations per business needs.
• 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
• Perform new equipment FAT / SAT / inspections in project in relation to utility
• 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

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

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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