CSV Engineer: Validate MES & GxP Systems

ECLARO

Bothell (WA)

On-site

USD 106,000 - 112,000

Full time

3 days ago

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Benefits offered by this job

401k Retirement Savings Plan

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Medical, Dental & Vision Insurance

Job summary

ECLARO is seeking a Computer System Validation Engineer in Bothell, WA to lead validation activities for GxP electronic systems. This role focuses on MES and database systems within a biopharma context, operating as an independent contributor.

The position requires a life sciences or engineering/IT degree with 4+ years of CSV experience and strong knowledge of GAMP, 21 CFR Part 11, and electronic records management. Apply today to join a global healthcare solutions company.

Qualifications

Bachelor's degree in life sciences, engineering, or IT; 4+ years CSV experience.
Knowledge of cGMP, GXP, GAMP, 21 CFR Part 11 and electronic records.
Experience with MES/ERP systems and electronic validation documentation.
Strong communication with technical and non-technical teams; independent contributor.

Responsibilities

Lead and execute validation for GxP electronic systems throughout the lifecycle.
Author, review, and approve CSV documentation and test scripts (IQ/OQ/PQ).
Support requirements, specifications, traceability, and change controls.
Collaborate with owners and Quality to ensure compliant validation deliverables.