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CSV Engineer

  • Type Contract
  • Salary competitive
  • Location Singapore, Singapore
  • Sectors Engineering

Computer Systems Validation Engineer

Company Description

Our client is one of the largest Pharmaceutical MNC's globally. They are looking for a CSV Engineer to join their team in Singapore. This position is an exciting opportunity that allows you to work closely and contribute to the success of the Engineering department.

Details

Title: CSV Engineer

Location: Singapore

Salary: Competitive market rate

Duration: 9 month contract initially

Purpose

In this role as CSV Engineer, you will be fundamental in providing system validation expertise to support the transfer of product lines. You will have the opportunity to provide support capital projects while delivering high quality installations.

Responsibilities

  • Develop CSV planning documents to manage tech transfer projects
  • Generate and execute CSV protocols (IQ/OQ/PQ) using Good Documentation Practices (GDPs)
  • Assure compliance of validated automated systems for existing manufacturing facilities
  • Writing comprehensive final reports containing thorough resolution of protocol discrepancies
  • Investigate and resolve protocol exceptions or discrepancies
  • Start-up equipment and systems in a safe and effective manner
  • Perform risk assessments and impact assessments
  • Develop GxP computer validation and CFR 21 Part 11 related documentation such as assessments, plans, URS, FRS and summary reports

Requirements

  • Minimum 7 years' experience validating GxP systems within the pharmaceutical, biotech, or medical device fields
  • Able to create computer system validation (CSV) deliverables (Validation Plans, Requirements, Design Specs, Test Scripts (IQ / OQ / PQ), Summary Reports, Trace Matrices, SOPs)
  • Familiar with Windows based system validation
  • Working experience with Quality Management System (QMS) records (e.g. Deviations, CAPAs, Change Management)

Keywords: CSV Engineer, Validation Engineering, System Validation, Pharmaceutical, Projects

If you are interested in the above described position, appreciate if you can send your CV or contact Naavin at +65 6871 4700 for a confidential discussion.

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