Laboratory System Validation Specialist

2 days ago

Singapore beBeeDataValidation Full time $110,000 - $140,000
System Validation Engineer - Laboratory Expertise

We are seeking an accomplished System Validation Engineer with in-depth experience in Computer System Validation (CSV) for laboratory and analytical equipment within regulated environments. The ideal candidate will bring extensive expertise in 21 CFR Part 11, audit trails, and data integrity controls.


Main Responsibilities:
  • Lead CSV activities for laboratory/analytical equipment ensuring compliance with regulations, standards, and quality requirements.
  • Draft and execute validation deliverables (URS, Risk Assessments, Test Scripts, IQ/OQ/PQ, Traceability).
  • Assess and implement audit trail review requirements and system access controls.
  • Support integration of instruments with PC networks and enterprise systems.
  • Prepare and review SOPs validation documentation and lifecycle deliverables.
  • Collaborate with QA QC IT and system owners to ensure compliant system deployment.

Qualifications & Requirements:
  • Bachelor's degree in Engineering Computer Science Life Sciences or related field.
  • 5–10 years of hands-on CSV experience in analytical instruments.
  • Strong knowledge of 21 CFR Part 11 audit trails data integrity Windows OS.
  • Exposure to microbiology analytical equipment is advantageous.
  • Experience with Kneat validation management system preferred.
  • Excellent problem-solving documentation skills required.

Why This Role Matters

This position offers a unique opportunity to leverage your expertise in system validation and contribute to the success of our team. If you are passionate about delivering high-quality results and committed to excellence, we encourage you to apply for this exciting opportunity.


About Us

We are a dynamic organization dedicated to innovation and excellence. Our team is comprised of talented professionals who share a common goal of delivering exceptional results. We value collaboration, continuous learning, and growth opportunities.


What We Offer

We offer a competitive compensation package, comprehensive benefits, and opportunities for professional growth and development. If you are looking for a challenging and rewarding career, we invite you to explore this opportunity further.

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