0065V6421 CSV Engineer (Laboratory)/Validation Engineer 2 Consultant
Two River Consulting Partners
Job Description
Job Description
0065V6421 CSV Engineer (Laboratory)/Validation Engineer 2 Consultant
Please contact Amanda Mazza, View email address on us.fitly.work
- 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
50% onsite in Summit, NJ EMPLOYMENT
Competitive C2C or W2 Contractor
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Vacancy posted a month ago
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