0065V6421 CSV Engineer (Laboratory)/Validation Engineer 2 Consultant

Experience with ELLA and Synergy Neo2

The ideal candidate should have hands-on experience supporting GxP laboratory instrument implementations and be comfortable managing validation activities for both technologies in parallel.

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

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