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Two River Consulting Partners

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

Summit, New Jersey, United States · Hybrid

Senior

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 validatio…

Skills: CSV, Validation, GxP, ELLA, Synergy Neo2

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

Two River Consulting Partners

Summit, New Jersey, United States • Hybrid

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SeniorHybrid · 3 days in office

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  • Contract
  • Posted 25d ago
  • Apply by Sep 29
  • ~40 hrs/week

Responsibilities

Support the implementation and validation of ELLA and Synergy Neo2 laboratory instruments. Develop and execute validation deliverables including plans, risk assessments, and summary reports while ensuring GxP compliance.

Requirements

Requires strong CSV experience in a regulated life sciences environment with a preference for experience with ELLA and Synergy Neo2. Must be able to manage multiple validation workstreams and possess familiarity with IQ/OQ/PQ and Part 11 expectations.

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
 

Related keywords

CSVValidation EngineerGxPELLASynergy Neo221 CFR Part 11IQ/OQ/PQData IntegrityRisk-Based ValidationECQBiotechPharmaPlasmaManufacturing LaboratoryTraceability MatrixValidation Plan

About Two River Consulting Partners

LinkedInVisit site
Industry
Business Consulting and Services
Company size
2-10 employees
Headquarters
New York, NY
LinkedIn followers
373

Offices: New York, NY, US

View all jobs at Two River Consulting Partners

About Two River Consulting Partners

LinkedInVisit site
Industry
Business Consulting and Services
Company size
2-10 employees
Headquarters
New York, NY
LinkedIn followers
373

Offices: New York, NY, US

View all jobs at Two River Consulting Partners

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