CSV Validation Engineer – Lab Instruments (Hybrid/Onsite)

Two River Consulting Partners; Utah; Hybrid; USD 124,000 - 207,000; Full time

Job summary

Two River Consulting Partners seeks a CSV Engineer (Laboratory)/Validation Engineer 2 Consultant to support validation activities for ELLA and Synergy Neo2 in a biopharma/regulated setting. The role requires hands-on CSV implementation, risk assessment, and documentation across parallel instrument projects.

The candidate will partner with Quality, IT, and lab teams, ensuring timely delivery of validation plans, protocols, and reports while maintaining data integrity and Part 11 considerations.

Qualifications

• 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.

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 escalation risks, gaps, delays, or documentation issues.
• Support deviation resolution and documentation updates during protocol execution.

Skills

CSV validation

GxP compliance

Cross-functional teamwork

Data integrity

Regulatory knowledge

Tools

IQ/OQ/PQ

Job description

Two River Consulting Partners seeks a CSV Engineer (Laboratory)/Validation Engineer 2 Consultant to support validation activities for ELLA and Synergy Neo2 in a biopharma/regulated setting. The role requires hands-on CSV implementation, risk assessment, and documentation across parallel instrument projects.

The candidate will partner with Quality, IT, and lab teams, ensuring timely delivery of validation plans, protocols, and reports while maintaining data integrity and Part 11 considerations.