Senior CSV Engineer

PQE SINGAPORE PTE. LTD.

Sydney, Australia
6+ years computer system validation experience
Osisoft pi or aveva pi system support
Gamp5 and gxp regulatory compliance knowledge
This role involves driving validation, technical support, and compliance for Historian systems within regulated pharmaceutical projects

Job Summary

  • This role involves driving validation, technical support, and compliance for Historian systems within regulated pharmaceutical projects.
  • The engineer will develop and maintain comprehensive validation documentation including URS, FS, DS, IQ, OQ, and PQ reports.
  • Candidates must ensure data integrity while supporting system integrations with automation platforms like PLC and SCADA.

Matching Summary

This role involves driving validation, technical support, and compliance for Historian systems within regulated pharmaceutical projects.

Skills & Requirements

Must-have

  • 6+ years Computer System Validation experience
  • OSIsoft PI or AVEVA PI System support
  • GAMP5 and GxP regulatory compliance knowledge
  • PLC and SCADA system integration skills
  • Validation documentation URS FS DS IQ OQ PQ

Nice-to-have

  • Strong problem-solving abilities
  • Effective cross-functional collaboration
  • Independent work in fast-paced environments

Key Requirements

  • 6+ years CSV experience in regulated industries
  • Proven Historian system support experience
  • Knowledge of GAMP5 guidelines and data integrity

Work Rights

Not specified

Tailored Resume

Cover Letter