Job Description:
We are seeking a hands-on CSV and Validation Engineer to validate software used with laboratory instruments and lab informatics platforms. The role owns risk-based validation planning and execution aligned to EMA Annex 11 and 21 CFR Part 11, authors audit-ready documentation, and partners with QA/IT/Lab to transition systems to standardized SOPs. Responsibilities:
Plan and execute computer system validation using a risk-based CSA approach aligned to GAMP 5.
Validate instrument software and lab systems; author URS, FRS, DS, test plans, IQ/OQ/PQ, traceability, and validation summary reports.
Design and maintain infrastructure and data flow diagrams covering integrations, security, backup/restore, and audit trails.
Capture business and technical requirements; maintain a bidirectional requirements traceability matrix.
Execute test cycles, log defects, drive remediation, manage deviations/CAPA, and support inspections.
Ensure change control, periodic review, training effectiveness, and release readiness for validated systems.
Collaborate across QA/CSV, IT, and Lab teams; provide clear communication and stakeholder updates.
Requirements:
5 to 10+ years in CSV/validation within regulated labs or life sciences.
Strong knowledge of EMA Annex 11, 21 CFR Part 11, data integrity (ALCOA+), and GAMP 5.
Proven authorship of URS/FRS/DS, RTM, IQ/OQ/PQ, and validation summary reports.
Experience with LIMS, ELN, CDS, or instrument control software; familiarity with instrument integrations and middleware.
Proficiency with test and quality tools such as Client ALM/Jira/Xray, ValGenesis, Veeva, MasterControl, or TrackWise.
Excellent technical writing, organization, and cross- functional communication.
Numbers & Facts
Location
Jersey, NJ
Skills
Atlassian JIRAunmatched
Biologyunmatched
Change Controlunmatched
Code of Federal Regulationsunmatched
Communication Skillsunmatched
Computer Systemsunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Cross-Functionalunmatched
Data Qualityunmatched
Data Recoveryunmatched
Documentationunmatched
Informaticsunmatched
Laboratory Information Management System (LIMS)unmatched
Laboratory Systemsunmatched
Middlewareunmatched
Process Validationunmatched
Quality Assuranceunmatched
Radiographyunmatched
Riskunmatched
Software Engineeringunmatched
Software Validationunmatched
Standard Operating Procedures (SOP)unmatched
System Validationunmatched
Technical Writingunmatched
Test Plan/Scheduleunmatched
Test Toolsunmatched
Testingunmatched
Traceabilityunmatched
Validation Planunmatched
Writing Skillsunmatched
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