QA CSV Engineer

Location: Singapore Salary: competitive
Sector: Engineering & Validation Type: Contract

CSV Engineer (12 months contract)

My client, a global pharmaceutical MNC is looking for a Quality CSV Engineer on an initial 12 months contract. This role reports into the Validation Manager, and will directly assist and contribute to the success of the Quality department

This position shall be responsible for the development and execution of CSV/CQV documentation on a variety of equipment, facilities, utilities, components, products, and computerized systems.

Key Responsibilities

  • Perform analysis, system design, implementation and validation of manufacturing systems
  • Develop computer system validation user and functional requirements
  • Performing risk assessments and reviewing of technical packages
  • Develop and write project execution plans
  • Develop computer system validation test documentation and perform data integrity testing

Minimum Requirements

  • Degree in Engineering or related field
  • 2 years of relevant experience in pharma/biotech/medical device industry
  • Knowledge and understanding of 21 CFR Part 11 & GMP

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