CSV Engineer - MES & GMP Validation Specialist

Net2Source (N2S)

Bothell (WA)

On-site

USD 96,000 - 103,000

Full time

3 days ago
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Job summary

Net2Source Inc. is seeking a Computer System Validation Engineer to lead validation activities for GxP electronic systems in a fast-paced environment.

This role requires collaboration with Business Owners, Technical Owners, and Quality to ensure compliant validation across MES platforms. The ideal candidate will have 4+ years in CSV, strong knowledge of GAMP and 21 CFR Part 11, and proven ability to develop and review validation documentation.

Qualifications

  • Bachelor's degree in life sciences or engineering/IT discipline or equivalent.
  • 4+ years of direct CSV experience and familiarity with GAMP / risk-based validation approaches.

Responsibilities

  • Author, review and/or approve CSV documentation.
  • Assist validation activities during test execution and document results.
  • Develop requirements and specifications for computerized systems used in GxP operations.
  • Manage validation deliverables across MES systems and electronic records workflow.

Skills

CSV experience
MES familiarity
Protocol drafting
Communication

Education

Bachelors in life sciences/engineering

Tools

ServiceNow
Veeva
SAP/Oracle

Job description

Net2Source Inc. is seeking a Computer System Validation Engineer to lead validation activities for GxP electronic systems in a fast-paced environment.

This role requires collaboration with Business Owners, Technical Owners, and Quality to ensure compliant validation across MES platforms. The ideal candidate will have 4+ years in CSV, strong knowledge of GAMP and 21 CFR Part 11, and proven ability to develop and review validation documentation.

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