0065V6421 CSV Engineer (Laboratory)/Validation Engineer 2 Consultant Two River Consulting Partners Summit, NJ Job Details 3 hours ago Qualifications Data integrity assurance Data compliance Laboratory equipment performance testing and validation GxP Pharmaceutical regulatory compliance Laboratory instrument validation Direct client contact
FDA 21 CFR
Part 11 Data integrity and documentation Compliance documentation Cross-functional collaboration Cross-functional communication Full Job Description 0065V6421 CSV Engineer (Laboratory)/Validation Engineer 2 Consultant Please contact
Amanda Mazza, 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 Neo2•
Validation 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.
