LIMS SME(Laboratory Information Management System Subject Matter Expert)

Highland Heights, OH - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Job Description:

We are seeking a highly experienced Laboratory Information Management System (LIMS) Subject Matter Expert (SME) with 10 years of proven expertise in the implementation optimization and support of LIMS solutions within clinical and research laboratory environments. The ideal candidate will serve as a key bridge between laboratory users IT teams and LIMS vendors ensuring the system meets operational needs regulatory requirements and business goals.
This role requires advanced skills in business process analysis system configuration workflow automation system integration and user enablement along with hands-on leadership in regulatory compliance and data integrity practices.

Responsibilities:

System Expertise & Leadership.
Serve as the primary LIMS SME with deep knowledge of LIMS architecture modules and workflows including sample management workflow automation and data reporting.
Provide strategic guidance on LIMS best practices and future technology roadmaps.
Implementation & Configuration.
Lead installations configurations and system customizations to align LIMS with business requirements clinical workflows and regulatory compliance.
Design and implement workflow automation solutions for improved lab efficiency.
Process Analysis & Optimization.
Conduct end-to-end business process analysis documenting current workflows and recommending optimized future-state solutions.
Translate laboratory needs into functional and technical specifications.
Integration & Data Management.
Manage LIMS integrations with analytical instruments ELNs ERP systems and data warehouses.
Ensure data integrity interoperability and traceability across connected systems.
Stakeholder Engagement.
Act as the primary liaison between laboratory staff IT and LIMS vendors.
Capture and prioritize user requirements oversee vendor deliverables and ensure timely resolution of system issues.
Training Documentation & Support.
Develop and maintain user requirements documentation SOPs validation documents and training materials.
Provide hands-on training to lab users and technical staff.
Lead knowledge transfer sessions across global teams.
Regulatory Compliance & Quality Assurance.
Ensure LIMS meets regulatory standards such as FDA 21 CFR Part 11 GxP GLP GMP and ISO guidelines.
Oversee system validation activities risk assessments and periodic audits.
System Enhancements & Upgrades.
Lead system upgrade planning testing and deployment while minimizing operational disruption.
Leverage new product capabilities to drive continuous improvement.

Requirements:

Bachelors or masters degree in Life Sciences Biotechnology Pharmaceutical Sciences Chemistry Computer Science or related discipline.
Additional certifications in LIMS administration Computer System Validation (CSV) GAMP 5 or Quality/Regulatory Compliance are highly desirable.
10 years of experience implementing supporting and optimizing LIMS in clinical and/or research laboratory environments.
5 years of specialized expertise in the following areas:
System configuration and customization (workflow design master data setup role/permission management).
Integration of LIMS with instruments (e.g. chromatography spectroscopy sequencing) ELNs and ERP systems.
Validation & compliance documentation (URS FRS validation protocols traceability matrices audit reports).
Process analysis and optimization for laboratory operations.
User training SOP development and system lifecycle documentation.
Regulatory compliance with FDA 21 CFR Part 11 GLP GMP GAMP 5 ISO 17025 and data integrity principles.
Strong experience in bridging technical and business teams to deliver optimized solutions.
Excellent communication stakeholder management and vendor engagement skills.
Ability to manage multiple projects simultaneously with global team collaboration.

Job Description: We are seeking a highly experienced Laboratory Information Management System (LIMS) Subject Matter Expert (SME) with 10 years of proven expertise in the implementation optimization and support of LIMS solutions within clinical and research laboratory environments. The ideal candida...

Job Description:

We are seeking a highly experienced Laboratory Information Management System (LIMS) Subject Matter Expert (SME) with 10 years of proven expertise in the implementation optimization and support of LIMS solutions within clinical and research laboratory environments. The ideal candidate will serve as a key bridge between laboratory users IT teams and LIMS vendors ensuring the system meets operational needs regulatory requirements and business goals.
This role requires advanced skills in business process analysis system configuration workflow automation system integration and user enablement along with hands-on leadership in regulatory compliance and data integrity practices.

Responsibilities:

System Expertise & Leadership.
Serve as the primary LIMS SME with deep knowledge of LIMS architecture modules and workflows including sample management workflow automation and data reporting.
Provide strategic guidance on LIMS best practices and future technology roadmaps.
Implementation & Configuration.
Lead installations configurations and system customizations to align LIMS with business requirements clinical workflows and regulatory compliance.
Design and implement workflow automation solutions for improved lab efficiency.
Process Analysis & Optimization.
Conduct end-to-end business process analysis documenting current workflows and recommending optimized future-state solutions.
Translate laboratory needs into functional and technical specifications.
Integration & Data Management.
Manage LIMS integrations with analytical instruments ELNs ERP systems and data warehouses.
Ensure data integrity interoperability and traceability across connected systems.
Stakeholder Engagement.
Act as the primary liaison between laboratory staff IT and LIMS vendors.
Capture and prioritize user requirements oversee vendor deliverables and ensure timely resolution of system issues.
Training Documentation & Support.
Develop and maintain user requirements documentation SOPs validation documents and training materials.
Provide hands-on training to lab users and technical staff.
Lead knowledge transfer sessions across global teams.
Regulatory Compliance & Quality Assurance.
Ensure LIMS meets regulatory standards such as FDA 21 CFR Part 11 GxP GLP GMP and ISO guidelines.
Oversee system validation activities risk assessments and periodic audits.
System Enhancements & Upgrades.
Lead system upgrade planning testing and deployment while minimizing operational disruption.
Leverage new product capabilities to drive continuous improvement.

Requirements:

Bachelors or masters degree in Life Sciences Biotechnology Pharmaceutical Sciences Chemistry Computer Science or related discipline.
Additional certifications in LIMS administration Computer System Validation (CSV) GAMP 5 or Quality/Regulatory Compliance are highly desirable.
10 years of experience implementing supporting and optimizing LIMS in clinical and/or research laboratory environments.
5 years of specialized expertise in the following areas:
System configuration and customization (workflow design master data setup role/permission management).
Integration of LIMS with instruments (e.g. chromatography spectroscopy sequencing) ELNs and ERP systems.
Validation & compliance documentation (URS FRS validation protocols traceability matrices audit reports).
Process analysis and optimization for laboratory operations.
User training SOP development and system lifecycle documentation.
Regulatory compliance with FDA 21 CFR Part 11 GLP GMP GAMP 5 ISO 17025 and data integrity principles.
Strong experience in bridging technical and business teams to deliver optimized solutions.
Excellent communication stakeholder management and vendor engagement skills.
Ability to manage multiple projects simultaneously with global team collaboration.