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LIMS Integration & Validation Engineer(LabWare LIMS )

QvalFocus Inc.

Job Summary

We are seeking a skilled LIMS Integration & Validation Engineer to support laboratory digital transformation and LIMS implementation initiatives in a regulated pharmaceutical environment. The ideal candidate will have strong hands-on experience with LabWare LIMS, GxP validation, and laboratory instrument integration , with the ability to contribute immediately and lead technical activities with minimal onboarding.

Key Responsibilities

  • Support LIMS migration and digital lab transformation projects.
  • Execute end-to-end GxP validation activities including URS, IQ, OQ, PQ, Traceability Matrix, and validation documentation.
  • Lead instrument-to-LIMS integration efforts across laboratory systems and analytical instruments.
  • Collaborate with Quality, IT, and Laboratory teams to define data flows, interfaces, and system requirements.
  • Ensure compliance with Data Integrity (ALCOA+) principles and regulatory requirements.
  • Support testing, issue resolution, change controls, and system lifecycle activities.
  • Drive the transition from manual laboratory processes to automated digital workflows.

Required Qualifications

  • 5+ years of experience in pharmaceutical, biotech, or regulated laboratory environments.
  • Strong hands-on experience with LabWare LIMS.
  • Extensive experience with GxP validation (URS, IQ/OQ/PQ).
  • Experience integrating laboratory instruments, CDS platforms (e.g., Empower), and LIMS systems.
  • Strong understanding of Data Integrity, GMP, and regulatory compliance.
  • Excellent communication and stakeholder management skills.

Top Skills

  • LabWare LIMS
  • GxP Validation (URS, IQ/OQ/PQ)
  • Instrument & System Integration
  • Data Integrity (ALCOA+)
  • Pharma/Biotech Laboratory Systems
Vacancy posted 1 day ago
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