Lead/Support aVeeva LIMS implementation and the validation activities throughout the system lifecycle, from requirements and design through testing, deployment, and validation closeout
Develop and/or review validation deliverables, including URS, risk assessments, validation plans, test scripts, traceability matrices, validation summary reports, and SOPs
Partner with Quality, Laboratory, IT, Business Process Owners, and system stakeholders to define requirements and ensure the LIMS meets business and regulatory needs
Support Veeva LIMS configuration, functional testing, integration testing, user acceptance testing, and defect resolution
Apply risk-based CSV/CSA principles and applicable GxP requirements to ensure the validated state of the system is maintained
Support data migration, interfaces, integrations, and related systems as part of the LIMS implementation
Participate in system change control, deviations, CAPAs, periodic reviews, and other lifecycle activities following implementation
Provide technical and validation expertise during implementation meetings, workshops, testing activities, and issue resolution
Ensure validation activities comply with applicable regulatory expectations, company procedures, and industry practices such as GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity principles
Support inspection and audit readiness by ensuring complete, accurate, and traceable validation documentation.
Requirements:
Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related technical discipline
5+ years of experience in computerized system validation, quality, or validation engineering within pharmaceutical, biotechnology, or other GxP-regulated environments
Demonstrated experience with Veeva LIMS implementation, validation, or lifecycle management
Strong understanding of CSV/CSA methodologies, GxP requirements, risk-based validation, and data integrity
Experience developing and executing validation/testing documentation, including requirements, risk assessments, test protocols/scripts, traceability, and validation reports
Strong understanding of 21 CFR Part 11, EU Annex 11, GAMP 5, and applicable data integrity principles
Strong project management, organizational, communication, and problem-solving skills
Numbers & Facts
Location
Columbus, OH
Skills
Acceptance Testingunmatched
Biologyunmatched
Biotech and Pharmaceuticalunmatched
Business Processesunmatched
Change Controlunmatched
Code of Federal Regulationsunmatched
Computer Scienceunmatched
Data Migrationunmatched
Data Qualityunmatched
Functional Testingunmatched
GxPunmatched
Integration Testingunmatched
Laboratory Information Management System (LIMS)unmatched
Problem Solving Skillsunmatched
Project/Program Managementunmatched
Regulationsunmatched
Requirements Managementunmatched
Riskunmatched
Risk Analysisunmatched
Standard Operating Procedures (SOP)unmatched
System Lifecycleunmatched
System Validationunmatched
Test Designunmatched
Test Scriptsunmatched
Traceabilityunmatched
Validation Documentationunmatched
Validation Planunmatched
Validation Testingunmatched
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