<p>We respectfully request that 3rd parties refrain from contacting us regarding this posting.</p> <p>Overview:</p> <p>Our client is looking for a highly skilled and detail-oriented Computer Systems Validation Specialist with hands-on experience in LabVantage LIMS and Empower Chromatography Data Systems. This role is critical to ensuring that laboratory and enterprise systems are validated in compliance with FDA 21 CFR Part 11, GAMP 5, and other applicable regulatory standards. The ideal candidate will support validation planning, protocol development, execution, and documentation for new and existing systems across GxP environments.</p> <p>Responsibilities:</p> <ul> <li>Develop and execute validation deliverables including Validation Plans, User Requirements Specifications (URS), Functional Specifications (FS), IQ/OQ/PQ protocols, and Validation Summary Reports. </li><li>Lead or support validation efforts for LabVantage LIMS and Empower system integrations, including instrument interface assessments. </li><li>Ensure systems meet compliance requirements (e.g., 21 CFR Part 11, EU Annex 11) and align with GMP/GLP practices. </li><li>Conduct risk assessments, gap analyses, and periodic reviews for validated systems. </li><li>Collaborate with cross-functional teams including QA, IT, Lab Operations, and vendors to support system lifecycle activities. </li><li>Maintain and manage validation documentation, SOPs, and change control records. </li><li>Provide technical support and training to system users and stakeholders. </li><li>Participate in internal audits and support regulatory inspections as needed. </li></ul> <p>Qualifications:</p> <ul> <li>Bachelor's degree in Computer Science, Life Sciences, Engineering, or related field. </li><li>Minimum 5-7 years of experience in CSV within regulated industries (pharma, biotech, medical devices). </li><li>Proven expertise in validating LabVantage LIMS and Empower systems. </li><li>Strong understanding of GAMP 5, 21 CFR Part 11, ISO, and SOX compliance frameworks. </li><li>Experience with SDLC methodologies and documentation suites. </li><li>Familiarity with related systems such as TrackWise, Veeva Vault, SAP, or MES is a plus. </li><li>Excellent communication, documentation, and project management skills. </li></ul>