Job Summary:
Highly skilled and detail-oriented LIMS Functional Consultant to support the implementation, configuration, and ongoing optimization of our Laboratory Information Management System. The ideal candidate will act as the bridge between business users (scientists, lab managers, QA) and technical teams, ensuring the LIMS solution meets both business requirements and regulatory standards.
Key Responsibilities:
- Gather, document, and analyze user requirements from various laboratories and quality stakeholders.
- Translate business requirements into functional specifications for LIMS configuration.
- Design and validate LIMS workflows, sample lifecycle, test plans, instrument integration, and user roles.
- Implementation of STARLIMS ELN as Analytical Raw Data Worksheets based on existing templates.
- Configure and test LIMS modules and functionalities based on business needs.
- Work closely with technical teams for system customization, integration (e.g., with ERP, MES, ELN, CDS), and data migration.
- Develop and maintain functional documentation, including SOPs, URS, FRS, and training materials.
- Work closely with developers in customization of modules, reports, and workflows within the LIMS application to meet client-specific needs, especially in areas like sample lifecycle management and quality control.
- Coordinate with cross-functional teams (QA, IT, Business, Lab Users, Vendors) to gather validation requirements, ensure business alignment, and manage deliverables.
- Assess and documented the validation impact of STARLIMS configurations, interfaces, custom scripts, and instrument integrations.
- Ensure test scripts covered regulatory and business-critical functionalities including sample lifecycle, test result entry, reporting, and audit trails.
- Manage deviations, incidents, and change controls related to STARLIMS systems within a validated environment, ensuring proper documentation and resolution.
- Provide strategic guidance on validation approaches, risk mitigation, and best practices to ensure continuous compliance with regulatory requirements.
- Prepare and facilitated internal and external audits, supporting evidence generation, CAPA resolution, and audit readiness.
- Mentor junior team members on validation methodologies and ensured consistent application of CSV standards across STARLIMS projects.
- Develop and managed validation deliverables including Validation Plan, Risk Assessment, User Requirements Specification (URS), Functional Requirements (FRS), Design Specifications (DS), and Traceability Matrix.
- Support system validation activities (e.g., IQ, OQ, PQ) in regulated environments (e.g., GxP, FDA, ISO).
- Conduct user training and provide post-go-live support.
- Troubleshoot functional issues and coordinate resolutions with technical support.
- Ensure compliance with data integrity, security, and regulatory standards (e.g., 21 CFR Part 11, GAMP 5, ALCOA+).
Required Qualifications:
- Bachelor’s degree in Life Sciences, Computer Science, Information Technology, or related field.
- Master’s degree in Chemistry, Pharmacy or Information Technology
- 3–7+ years of experience in LIMS implementation or support (e.g., LabWare, LabVantage, STARLIMS, SampleManager).
- Strong understanding of laboratory processes, terminology, and regulatory requirements.
- Experience gathering and documenting business/functional requirements.
- Familiarity with system validation and documentation practices in regulated industries.
- Excellent communication and stakeholder management skills.
- Ability to work independently and in cross-functional teams.
Preferred Qualifications:
- Experience in pharmaceutical, biotech, or clinical lab environments.
- Knowledge of GxP, FDA 21 CFR Part 11, ISO 17025, or other regulatory frameworks.
- Experience with SQL, scripting, or reporting tools used in LIMS environments.
- Exposure to interfacing LIMS with other lab systems (e.g., ERP, ELN, CDS).
- LIMS certification or vendor-specific training (e.g., STARLIMS Certified Professional).