CSV Engineer: MES Validation & GxP Systems Lead

Katalyst CRO; Bothell (WA); On-site; USD 90,000 - 135,000; Full time

Job summary

Katalyst CRO in Bothell, WA, seeks a Computer System Validation (CSV) Engineer to lead validation activities for GxP electronic systems, especially MES, coordinating with Business Owners, Technical Owners, and Quality teams.

You will author and review CSV documentation, develop requirements, ensure SDLC and 21 CFR Part 11 compliance, and maintain Validation Plans, IQ/OQ/PQ, Trace Matrices, and SOPs across the validation lifecycle.

Qualifications

• Bachelor's degree required in Life Sciences, Engineering, IT, or related field.
• Minimum 4+ years direct CSV experience in regulated environments.
• Strong knowledge of GAMP and risk-based validation.
• Understanding of electronic records and electronic signatures.
• Solid MES validation experience.
• Familiarity with MES such as Emerson Syncade, SAP/Oracle, and InfoBatch.
• Experience developing CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts, Reports, Trace Matrices, SOPs).

Responsibilities

• Author, review, and approve CSV documentation.
• Lead and execute validation activities for GxP electronic systems.
• Partner with Business Owners, Technical Owners, and Quality teams.
• Develop requirements and specifications for computerized systems.
• Support MES validation activities.
• Maintain CSV documentation across the validation lifecycle.
• Ensure compliance with cGMP, GxP, GAMP, 21 CFR Part 11 and Good Documentation Practices.
• Utilize IT service management platforms for incident/problem/change management.

Skills

GAMP knowledge

Risk-based validation

Electronic records & signatures

MES validation

GxP compliance

Education

Bachelor's degree in Life Sciences, Engineering, IT, or related

Tools

ServiceNow

InfoBatch

Emerson Syncade

SAP

Oracle

Job description

Katalyst CRO in Bothell, WA, seeks a Computer System Validation (CSV) Engineer to lead validation activities for GxP electronic systems, especially MES, coordinating with Business Owners, Technical Owners, and Quality teams.

You will author and review CSV documentation, develop requirements, ensure SDLC and 21 CFR Part 11 compliance, and maintain Validation Plans, IQ/OQ/PQ, Trace Matrices, and SOPs across the validation lifecycle.