Two River Consulting Partners

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

Summit, NJ
Contracted
Mid Level
0065V6421 CSV Engineer (Laboratory)/Validation Engineer 2 Consultant  
Please contact Amanda Mazza, [email protected]

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.

LOCATION
50% onsite in Summit, NJ

EMPLOYMENT
Competitive C2C or W2 Contractor
 
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