Labware LIMS Integration & Validation Consultant

QvalFocus Inc.; California; Hybrid; USD 120,000 - 160,000; Full time

Job summary

QvalFocus Inc. is seeking an experienced Labware LIMS Integration & Validation Consultant to support laboratory digitalization and GxP validation within a regulated pharma/biotech setting. The role emphasizes LIMS integration, instrument interfaces, and validation execution.

You will author URS/IQ/OQ/PQ, coordinate cross-disciplinary teams, ensure ALCOA+ data integrity, and help transition manual workflows to electronic systems while maintaining robust validation documentation.

Qualifications

• Experience with GxP computer system validation in regulated life-science environments.
• Experience with LIMS platforms, preferably LabWare or similar.
• Experience integrating laboratory instruments with LIMS or informatics systems.
• Understanding of analytical workflows and systems (Empower/CDS, chromatography instruments, balances, pH meters, etc.).
• Strong knowledge of URS, IQ/OQ/PQ, RTM, testing, data integrity and validation documentation.
• Understanding ALCOA+ and regulatory expectations for electronic lab data.
• Ability to collaborate across Laboratory, Quality, IT, Automation and business teams; strong troubleshooting skills.

Responsibilities

• Support implementation and validation of LIMS in a regulated GxP environment.
• Author and execute validation lifecycle documentation (URS, IQ, OQ, PQ, traceability).
• Assist integration of laboratory instruments with LIMS and informatics systems.
• Define data flows, system interfaces, and integration requirements with cross-functional teams.
• Transition manual lab processes to electronic and automated workflows.
• Perform testing and troubleshoot data-flow or integration issues during validation.
• Ensure data integrity and ALCOA+ compliance across lab systems.
• Maintain validation documentation and support system changes through the lifecycle.

Skills

LIMS integration

GxP validation

data integrity

troubleshooting

cross-functional collaboration

Tools

LabWare LIMS

Empower CDS

Validation docs tools

Job description

Job Title: Labware LIMS Integration & Validation Consultant

Location: California (50% Remote)

Duration: 24+ Months

Job Description

We are looking for an experienced LIMS Integration & Validation Engineer to support laboratory digitalization and GxP validation activities within a regulated pharmaceutical or biotechnology environment. The ideal candidate will have a combination of LIMS, laboratory instrument integration, CSV/validation, and analytical laboratory experience.

Key Responsibilities

• Support implementation and validation of LIMS and digital laboratory solutions in a regulated GxP environment.
• Author and execute validation lifecycle documentation including URS, IQ, OQ, PQ, traceability, and validation reports.
• Support integration of laboratory instruments and analytical systems with LIMS, including chromatography systems and standalone laboratory equipment.
• Work with laboratory, IT, Quality, and technical teams to define data flows, system interfaces, and integration requirements.
• Support transition of manual laboratory processes into electronic and automated workflows.
• Perform testing, troubleshoot integration or data-flow issues, and support resolution through implementation and validation.
• Ensure laboratory systems and integrations meet data integrity and ALCOA+ expectations.
• Maintain validation documentation and support system changes throughout the application lifecycle.

Qualifications

• Strong hands-on experience with GxP computer system validation within pharmaceutical, biotechnology, or other regulated life-sciences environments.
• Experience with LIMS platforms, preferably LabWare or similar enterprise LIMS applications.
• Experience integrating laboratory instruments with LIMS or laboratory informatics systems.
• Good understanding of analytical laboratory workflows and systems such as Empower/CDS, chromatography instruments, balances, pH meters, and other laboratory equipment.
• Strong knowledge of URS, IQ/OQ/PQ, RTM, testing, data integrity, and validation documentation.
• Understanding of ALCOA+ and regulatory expectations for electronic laboratory data.
• Ability to work effectively across Laboratory, Quality, IT, Automation, and business teams. Strong troubleshooting and problem-solving skills in evolving project environments.