Job Overview: We are seeking an experienced CSV Engineer to support the implementation and validation of ELLA and Synergy Neo2 laboratory instruments. The ideal candidate should have hands-on experience supporting GxP laboratory instrument implementations and be comfortable managing validation activities for both technologies in parallel.Experience with ELLA and Synergy Neo2Validation Engineer Responsibilities:
Support CSV activities for ELLA and Synergy Neo2 instrument implementation
Develop, review, and/or execute validation deliverables including validation plans, risk assessments, test protocols, traceability matrices, summary reports, and related documentation
Partner with laboratory, Quality, IT, and project stakeholders to ensure validation activities are completed on schedule
Support GxP compliance, data integrity, and 21 CFR Part 11 considerations as applicable
Manage validation workstreams for both instruments simultaneously
Identify and escalate risks, gaps, delays, or documentation issues
Support deviation resolution and documentation updates during protocol execution
Job Requirements:
Strong CSV experience in a GxP laboratory or regulated life sciences environment
Prior experience with laboratory instrument implementation and validation
Experience with ELLA and Synergy Neo2 strongly preferred
Ability to manage multiple validation activities or technologies concurrently
Familiarity with IQ/OQ/PQ, CSV lifecycle documentation, risk-based validation, data integrity, and Part 11 expectations
Strong communication skills and ability to work effectively with cross-functional teams
Experience supporting ECQ or lab equipment qualification
Experience in biotech, pharma, plasma, or manufacturing laboratory environments
Prior experience working in client-facing hybrid/onsite roles
This role can be a local/hybrid setup. At minimum, a 50% on-site presence is required.LOCATION50% onsite in Summit, NJEMPLOYMENT Competitive C2C or W2 Contractor
Powered by JazzHR
Numbers & Facts
Location
Summit, NJ
Skills
Biologyunmatched
Biotech and Pharmaceuticalunmatched
Code of Federal Regulationsunmatched
Communication Skillsunmatched
Cross-Functionalunmatched
Customer Relationsunmatched
Data Qualityunmatched
Documentationunmatched
Engineering Consultingunmatched
Environmental Sciencesunmatched
GxPunmatched
Laboratoryunmatched
Laboratory Equipmentunmatched
Manufacturingunmatched
Plasmaunmatched
Process Validationunmatched
Riskunmatched
Risk Analysisunmatched
Testingunmatched
Time Managementunmatched
Traceabilityunmatched
Validation Planunmatched
🎯
Be found by employers
5,500+ employers search our resume database daily. Add yours to get found by recruiters looking for candidates like you.
Level up your application
Professional resume templates
Browse dozens of recruiter approved resume templates, layouts and formats. Choose your favorite and make it your own in minutes.