Labware LIMS Integration & Validation Consultant

QvalFocus Inc.; California; Híbrido; USD 120.000 - 180.000; Jornada completa

Descripción de la vacante

QvalFocus Inc. is seeking an experienced Labware LIMS Integration & Validation Consultant to support laboratory digitalization and GxP validation in California with 50% remote work.

The role focuses on integrating LIMS with instruments, authoring validation documents (URS, IQ, OQ, PQ), and ensuring data integrity while collaborating across lab, IT, QA, and automation teams. Candidates should have hands-on LIMS/LabWare experience, familiarity with Empower/CDS, and a strong track record in

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

LIMS (LabWare)

GxP validation

Data integrity

URS/IQ/OQ/PQ

ALCOA+

Cross-team collaboration

Laboratory IT

Empower/CDS

Herramientas

LabWare LIMS

Empower/CDS

Descripción del empleo

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.