LIMS Consultant | Regulated Lab Solutions

Clarkston Consulting; Wilmington (DE); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Comprehensive Health benefits

401k with company contributions

Paid vacation and holidays

Parental Leave and Family Building

Job summary

Clarkston Consulting seeks a LIMS Consultant to deliver solutions in life sciences, consumer products, and retail sectors. You will configure LIMS modules, develop workflows, and validate systems to meet GxP and 21 CFR Part 11 requirements. Travel 30-50% with home-office days when not on client sites.

You will collaborate with scientists, QA/CSV, and IT to gather requirements, create demos, and support validation activities across multiple client engagements.

Qualifications

• Minimum of 2 years hands-on experience with LabWare or LabVantage LIMS.
• Experience configuring and customizing LabWare or LabVantage LIMS to support laboratory workflows.
• Proven ability to design, configure, and validate assay workflows.
• Experience developing and maintaining scripts for workflow automation, business rules, calculations, instrument integrations, and data transformations.
• Strong knowledge of GxP, 21 CFR Part 11 and other applicable regulatory requirements.
• 4-year degree in Life Sciences, Information Technology, or related discipline.
• Excellent communication and collaboration skills across cross-functional teams.

Responsibilities

• Configure LIMS modules to support workflows (assay development, plate results, sample management, stability, and analytical testing).
• Design, configure, and validate assay workflows to align with regulatory requirements.
• Develop and maintain scripts for workflow automation, data transformation, and instrument integration.
• Prepare project documentation and conduct configuration demos for clients.
• Collaborate with scientists, QA/CSV, and IT to gather requirements and support system validation (URS, FRS, DS, IQ/OQ/PQ).
• Ensure configurations comply with 21 CFR Part 11 and related validation procedures.
• Coordinate with LIMS consultants across sites for deployment.

Skills

LabWare LIMS

LabVantage LIMS

Workflow automation scripting

Regulatory compliance

Cross-functional collaboration

Client demos & documentation

Education

Life Sciences or IT degree

Tools

LabWare/LIMS

LabVantage LIMS

Job description

Clarkston Consulting seeks a LIMS Consultant to deliver solutions in life sciences, consumer products, and retail sectors. You will configure LIMS modules, develop workflows, and validate systems to meet GxP and 21 CFR Part 11 requirements. Travel 30-50% with home-office days when not on client sites.

You will collaborate with scientists, QA/CSV, and IT to gather requirements, create demos, and support validation activities across multiple client engagements.