What are the responsibilities and job description for the LabWare LIMS Validation Specialist position at Intellectt Inc?
We are seeking an experienced LabWare LIMS Validation Specialist to support validation activities for laboratory systems within a regulated pharmaceutical environment. The ideal candidate will possess strong experience in Computer System Validation (CSV) and LabWare LIMS, ensuring systems remain compliant with GMP and regulatory requirements.
Key Responsibilities:
- Execute validation activities for LabWare LIMS in accordance with GxP, FDA, and industry regulations.
- Author, review, and execute validation documentation including URS, Risk Assessments, IQ, OQ, PQ, Traceability Matrix, and Validation Summary Reports.
- Collaborate with business, quality, and IT teams to gather and document system requirements.
- Support change controls, deviations, CAPAs, and periodic reviews related to LabWare LIMS.
- Ensure compliance with 21 CFR Part 11, GAMP 5, and internal quality standards.
- Participate in system upgrades, enhancements, and remediation activities.
- Provide validation support during audits and inspections.
Required Qualifications:
- Bachelor's degree in Life Sciences, Engineering, Computer Science, or related field.
- 5 years of Computer System Validation experience within the pharmaceutical or biotechnology industry.
- Hands-on experience validating LabWare LIMS applications.
- Strong knowledge of GxP, FDA regulations, 21 CFR Part 11, and GAMP 5.
- Excellent documentation and stakeholder management skills.