Computer System Validation Engineer — GxP / MES

Job overview

The Computer System Validation Engineer role is onsite in Bothell, WA, with on-site support required during User Acceptance Testing. Compensation is not specified. The role supports computerized systems in pharmaceutical or biologics manufacturing. The engineer leads and executes validation across the lifecycle of GxP systems, with a focus on Manufacturing Execution Systems. The work helps ensure systems and electronic records meet quality and regulatory requirements through risk-based validation, testing, documentation, and cross-functional coordination.

What you'll do

• Lead and execute CSV activities for GxP systems and applications
• develop, review, execute, and maintain validation plans, requirements, specifications, risk assessments, IQ/OQ/PQ protocols, traceability matrices, reports, and SOPs
• support MES validation and UAT
• develop system requirements
• perform risk-based validation using GAMP
• support change control, incident management, and system lifecycle activities
• maintain audit-ready documentation and collaborate with Quality, Manufacturing, Engineering, and IT.

What we're looking for

Skills & competencies

computer system validation engineer

bothell wa

karwell technologies

csv

gxp

mes validation

gamp 5

21 cfr part 11

cgmp

uat

iq/oq/pq

pharmaceutical manufacturing

Work arrangement

• Weekend coverage required

Why this role

The posting requires four years of CSV experience in a GxP-regulated pharmaceutical, biotechnology, or biologics manufacturing environment and hands-on MES validation experience.

About the employer

Karwell Technologies is hiring for this role. Industry: Computer Systems Design Services. Sector: 54.