Commissioning & Qualification Engineer

Commissioning & Qualification Engineer

REQ-10030465
Nov 18, 2024
China

About the Role

Strategy & Organizational Development:

  • Support internal and external audits
  • Create and maintain GOPs and provide standard training
  • Implement GOPs
  • If needed, create regional / site SOPs & templates
  • C&Q related IT system owner for Haiyan Site

Project Engineering & Control:

  • Develop Project schedule
  • Perform project risk assessment
  • Identify technical solutions
  • Prepare project quality plan
  • Develop project document management and archiving concept
  • Perform project reviews (e.g. Technical Quality Review (TQR), constructability, sustainability, HSE)
  • Develop project commissioning plan / strategy
  • Establish project change management and manage changes
  • Develop project execution plan (e.g. C&Q)
  • Prepare / execute Project Health & Safety Risk Assessments (Equipment / Process)
  • Expedite and manage project vendors / contractors / 3rd parties in project
  • Develop test specification / plan for commissioning & qualification in projects
  • Perform new equipment FAT / SAT / inspections in project
  • Implement and monitor construction contractor safety and inspection plan
  • Execute work orders for projects as per method statement
  • Perform commissioning activities
  • Manage project deficiencies and deviations
  • Perform provisional and final project handover

Maintenance & Calibration:

  • Plan initial calibrations
  • Coordinate maintenance / calibration activities
  • Plan resources for maintenance / calibration
  • Allocate work for maintenance / calibration to technicians
  • Identify spare parts for maintenance and maintain pick-lists
  • Establish Master Instrument Inventory (MII) and Master Equipment Inventory (MEI)
  • Get permits for maintenance / calibration / projects
  • Execute work orders for maintenance / calibration as per method statement / procedure
  • Provide front line support for technicians
  • Supervise maintenance and calibration works
  • Assess quality impact and release after maintenance work
  • Manage technical / engineering changes: originate Change Request, approve Change Request,  close Change Request
  • Execute change requests
  • Investigate deviations (root cause analysis)
  • Create / maintain / verify engineering documents (protocols, drawings, lists, schedules, diagrams, layouts, calculations, datasheets)

 (Re-) Qualification:

  • Develop qualification plan
  • 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
  • Develop periodic requalification plan
  • Execute periodic requalification plan

Role Requirements

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

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Operations
Innovative Medicines
China
Haiyan (Zhejiang Province)
Technical Operations
Full time
Regular
No
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REQ-10030465

Commissioning & Qualification Engineer

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Source URL: https://jobapi.novartis.com/req-10030465-commissioning-qualification-engineer

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  3. https://talentnetwork.novartis.com/network
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  5. https://novartis.wd3.myworkdayjobs.com/en-US/Novartis_Careers/job/Haiyan-Zhejiang-Province/Commissioning---Qualification-Engineer_REQ-10030465
  6. https://novartis.wd3.myworkdayjobs.com/en-US/Novartis_Careers/job/Haiyan-Zhejiang-Province/Commissioning---Qualification-Engineer_REQ-10030465