Job Description

Position Overview

We are seeking an experienced Subject Matter Expert (SME) Consultant in LabVantage LIMS to support a major system implementation project for a Life Sciences organization in Winston-Salem, NC. This role will serve as a strategic and functional expert, ensuring the successful configuration, deployment, validation, and adoption of the LabVantage Laboratory Information Management System (LIMS).

The consultant will collaborate cross-functionally with Quality, IT, Laboratory Operations, and Validation teams to align system capabilities with business and regulatory requirements.

Key Responsibilities

  • Act as the LabVantage LIMS functional SME throughout the implementation lifecycle.

  • Gather, analyze, and document business and laboratory requirements.

  • Provide expert guidance on system configuration, workflows, data structures, and best practices.

  • Support system design, integration, testing, and validation activities.

  • Review and advise on data migration strategies and execution.

  • Ensure compliance with regulatory standards (GxP, FDA, 21 CFR Part 11, etc.).

  • Partner with project management and technical teams to resolve issues and mitigate risks.

  • Support user acceptance testing (UAT), training, and go-live readiness.

  • Provide post-implementation optimization recommendations.

Required Qualifications

  • Proven experience as a LabVantage LIMS SME in at least one full implementation.

  • Strong understanding of laboratory workflows within Life Sciences environments.

  • Demonstrated knowledge of system configuration, validation, and regulatory compliance.

  • Experience working with cross-functional stakeholders and technical teams.

  • Ability to translate business needs into functional system requirements.

  • Excellent communication, documentation, and stakeholder management skills.

Preferred Qualifications

  • Multiple LabVantage implementation or upgrade projects.

  • Experience with integrations (ERP, CDS, ELN, instruments, middleware).

  • Familiarity with data migration tools and strategies.

  • Background in Quality Control or R&D laboratory operations.

  • PMP, CBAP, or similar certification is a plus.

Work Environment & Travel

  • Onsite presence in Winston-Salem required during key project phases.

  • Remote work possible during planning, documentation, and support phases.

  • Occasional travel may be required depending on project milestones.

Ideal Candidate Profile

A results-driven consultant who combines deep LabVantage platform expertise with strong business process understanding and the ability to guide stakeholders through complex implementation decisions. The ideal candidate is proactive, solutions-oriented, and experienced in regulated environments.

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