Connecting...

QA CSV Engineer

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

Real, a trading division of SThree Pte Limited (Registration Number: 2007.20126E | SThree Pte Limited Licence Number 16S8216 | Real Licence Number 53132073A)

Award winner of:

International Recruitment Company of the Year by Recruitment International 2016

Life Sciences and Healthcare Recruitment Company of the Year by Recruitment International 2016

Best Overseas Operation by Global Recruiters 2017

Highly Commended for Best Large Recruitment Business 2017