CSV Laboratory Engineer

NO DEVIATION PTE. LTD.

Singapore
Gamp 5 knowledge
Fda 21 cfr part 11 compliance
Iq oq pq validation execution
The role ensures all laboratory computerized systems comply with regulatory, quality, and data integrity requirements

Job Summary

  • The role ensures all laboratory computerized systems comply with regulatory, quality, and data integrity requirements.
  • Candidates will lead validation activities including URS, IQ/OQ/PQ, and traceability matrix creation while maintaining a validated state.
  • The company offers generous leave policies, comprehensive health coverage, and opportunities for professional development in an inclusive culture.

Matching Summary

Match Score: 85

The role ensures all laboratory computerized systems comply with regulatory, quality, and data integrity requirements.

Skills & Requirements

Must-have

  • GAMP 5 knowledge
  • FDA 21 CFR Part 11 compliance
  • IQ OQ PQ validation execution
  • Data integrity ALCOA+ principles
  • URS and risk assessment authoring

Nice-to-have

  • Experience with analytical laboratory systems
  • Strong cross-functional collaboration skills
  • Vendor coordination experience
  • Troubleshooting CSV-related issues

Key Requirements

  • Degree in Engineering, Computer Science, or Life Sciences
  • 3-5 years of CSV experience in GMP environment
  • Proven experience validating laboratory computerized systems

Work Rights

Not specified

Tailored Resume

Cover Letter