What are the responsibilities and job description for the LIMS Integration & Validation Engineer(LabWare LIMS ) position at 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