0065V6421 CSV Engineer (Laboratory)/Validation Engineer 2 Consultant
HybridSummit, New Jersey, United States
Job Summary
Support CSV activities for ELLA and Synergy Neo2 instrument implementation by developing, reviewing, and executing validation deliverables including plans, risk assessments, test protocols, traceability matrices, and summary reports. Partner with laboratory, Quality, IT, and project stakeholders to ensure validation activities are completed on schedule while managing workstreams for both instruments simultaneously. Identify and escalate risks, gaps, delays, or documentation issues, and support deviation resolution and documentation updates during protocol execution. Ensure GxP compliance, data integrity, and 21 CFR Part 11 considerations are met. This role requires a 50% onsite presence in Summit, NJ, with a hybrid setup available.
Required Qualifications
- Strong CSV experience in a GxP laboratory or regulated life sciences environment
- Prior experience with laboratory instrument implementation and validation
- 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% on-site presence
Desired Qualifications
- Experience with ELLA and Synergy Neo2
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