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.