0065V6421 CSV Engineer (Laboratory)/Validation Engineer 2 Consultant
Two River Consulting PartnersSummit, NJ
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Overview
Career level
Senior-level
Remote
Hybrid remote
Job Description
0065V6421 CSV Engineer (Laboratory)/Validation Engineer 2 Consultant Please contact Amanda Mazza, amanda@tworivercp.comJob 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
- 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
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FAQs About 0065V6421 CSV Engineer (Laboratory)/Validation Engineer 2 Consultant Jobs at Two River Consulting Partners
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This job at Two River Consulting Partners is located in Summit, NJ, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
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What experience level is required for this role at Two River Consulting Partners?
Two River Consulting Partners is looking for a candidate with "Senior-level" experience level.
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