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0065V6421 CSV Engineer (Laboratory)/Validation Engineer 2 Consultant
Two River Consulting Partners —Summit, NJ
- Hybrid work
- Mid-level
- Communication skills
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0065V6421 CSV Engineer (Laboratory)/Validation Engineer 2 Consultant
Two River Consulting Partners —Summit, NJ
Experience in biotech, pharma, plasma, or manufacturing laboratory environments. Prior experience with laboratory instrument implementation and validation.
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0065V6421 CSV Engineer (Laboratory)/Validation Engineer 2 Consultant

Two River Consulting Partners
Summit, NJ

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Job Details

2 days ago

Qualifications

Data integrity assurance
Data compliance
Laboratory equipment performance testing and validation
GxP
Pharmaceutical regulatory compliance
Laboratory instrument validation
Direct client contact
FDA 21 CFR Part 11
Data integrity and documentation
Compliance documentation
Cross-functional collaboration
Cross-functional communication

Full Job Description

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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